Interventional procedure overview of ab interno canaloplasty for open-angle glaucoma
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Summary of key evidence on ab interno canaloplasty for open-angle glaucoma
Study 1 Gallardo MJ (2021)
Study type | Single centre, retrospective, before-and-after study |
|---|---|
Country | US |
Recruitment period | 2014 to 2016 |
Study population and number | n=53 people, 60 eyes Adults with primary open-angle glaucoma. |
Age and sex | Mean 73.6 years; 60% female |
Patient selection criteria | Inclusion criteria: adults (18 or older) with a diagnosis of mild-moderate, or severe primary open-angle glaucoma. Exclusion criteria: any sign of angle disease; had undergone laser trabeculoplasty within 6 months of surgery or other angle-based micro-invasive procedure; had neovascular disease, uveitis, peripheral anterior synechiae, or developmental or other forms of secondary glaucoma, such as steroid-induced glaucoma. |
Technique | Ab interno canaloplasty using the iTrack device. In 29 eyes, canaloplasty was concurrently with phacoemulsification. The microcatheter was inserted via a clear corneal incision and goniotomy into Schlemm's canal. The microcatheter was advanced 360 degrees, then withdrawn whilst depositing high-molecular-weight hyaluronic acid-based ophthalmic viscoelastic. Glaucoma treatments were stopped 1 day after surgery and only restarted if pressure rose above target. |
Follow up | 24 months |
Conflict of interest/source of funding | Conflict of interest: The author is an investigator, consultant, and speaker for Nova Eye Medical, the manufacturer of iTrack, and for Sight Sciences, the manufacturer of the OMNI and VISCO360 devices. Source of funding: Not reported. |
Analysis
Follow up issues: Although not explicitly described in the publication, this study captures a highly similar population as a 2018 study by the same author (as summarised in the appendix). In the 2018 study, the 12-month outcomes of 75 eyes in 68 people are described. This study describes the 24-month outcomes of 60 eyes in 53 people, implying 15 eyes were lost to follow up and were not included here.
Study design issues: This single centre, before-and-after study reported the 24-month outcomes of people who had ab interno canaloplasty for primary open-angle glaucoma. Cases were identified retrospectively from an analysis of patient records. Primary outcomes included mean IOP and mean number of glaucoma medicines at 12 and 24 months. Safety outcomes included complications and loss of visual acuity.
A repeated-measures ANOVA test was used to compare mean IOP and number of medicines between groups over time followed by a post hoc Tukey's test for multiple comparisons across the visits. p<0.05 was considered statistically significant. A t-test was performed to compare the percentage reduction in IOP and number of medicines between groups.
Study population issues: The study cohort consisted of people from Hispanic (74%), black (6%), or white (21%) ethnicity, and the glaucoma stages of mild (38%), moderate (17%) and severe (38%).
Key efficacy findings
IOP reduction
Number of people analysed: 53 people, 60 eyes
Follow up at time of assessment: 24 months
There was a statistically significant decrease in IOP from 20.7 mmHg (SD 4.9 mmHg) before surgery to 13.6 mmHg (SD 1.9 mmHg) at 12 months and 13.5 mmHg (SD 2.6 mmHg) at 24 months after surgery (both p<0.001 compared to baseline).
In 29 eyes that had canaloplasty plus phacoemulsification, there was a statistically significant decrease in IOP from 19.8 mmHg (SD 3.9 mmHg) before surgery to 13.0 mmHg (SD not reported) at 12 months and 13.2 mmHg (SD 2.1 mmHg) at 24 months after surgery (both p<0.001 compared to baseline).
In 31 eyes that had canaloplasty alone, there was a statistically significant decrease in IOP from 21.6 mmHg (SD 5.7 mmHg) before surgery to 14.1 mmHg (SD not reported) at 12 months and 13.8 mmHg (SD 3.1 mmHg) at 24 months after surgery (both p<0.001 compared to baseline).
There was no statistically significant difference in the IOP reduction between people who had canaloplasty alone and those who had canaloplasty and phacoemulsification.
There were similar decreases in IOP for people with mild/moderate glaucoma and for people with severe glaucoma.
Glaucoma medicine reduction
Number of people analysed: 53 people, 60 eyes
Follow up at time of assessment: 24 months
There was a statistically significant decrease in the mean number of glaucoma medicines used per person from 2.8 (SD 0.9) before surgery to 1.1 (SD 1.1) at 12 months and 1.7 (SD 1.3) at 24 months after surgery (both p<0.001 compared to baseline).
In 29 eyes that had canaloplasty plus phacoemulsification, there was a statistically significant decrease in the mean number of glaucoma medicines used per person from 2.5 (SD 1.1) before surgery to 0.8 (SD 0.9) at 12 months and 1.3 (SD 1.2) at 24 months after surgery (both p<0.001 compared to baseline).
In 31 eyes that had canaloplasty alone, there was a statistically significant decrease in the mean number of glaucoma medicines used per person from 3.0 (SD 0.7) before surgery to 1.4 (SD 1.2) at 12 months and 2.1 (SD 1.3) at 24 months after surgery (both p<0.001 compared to baseline).
There was no statistically significant difference in the reduction in glaucoma medicine use between people who had canaloplasty alone and those who had canaloplasty and phacoemulsification.
There were similar decreases in medicine use for people with mild/moderate glaucoma and for people with severe glaucoma.
Key safety findings
Complications
Number of people analysed: 53 people, 60 eyes
Follow up at time of assessment: 24 months
Intraoperative bleeding at the goniotomy site, number not specified
Microhyphaema, number not specified
Both resolved within 1 week without sequelae.
Visual acuity
Number of people analysed: 53 people, 60 eyes
Follow up at time of assessment: 24 months
Visual acuity was improved at 24-month follow up in all eyes, with 19 people (42.2%) gaining 2 or more lines of Snellen corrected distance visual acuity.
In 29 eyes that had canaloplasty plus phacoemulsification, there was a statistically significant improvement in the proportion of people with 20/40 vision from 34.5% before surgery to 80.8% at 24 months after surgery (p=0.0042).
In 31 eyes that had canaloplasty alone, there was no statistically significant change in the proportion of people with 20/40 vision from 64.5% before surgery to 70.0% at 24 months after surgery (p=0.4716).
Study details
Study type | Single centre, before-and-after study |
Country | US |
Recruitment period | 2015 to 2017 |
Study population and number | n=130 people, 180 eyes Adults with mild to moderate open-angle glaucoma. |
Age and sex | Mean 70 years; 52% female |
Patient selection criteria | Inclusion criteria: diagnosis of mild to moderate open-angle glaucoma (most were primary open-angle glaucoma). Exclusion criteria: advanced glaucoma, prior penetrating glaucoma surgery. |
Technique | Ab interno canaloplasty using the VISCO360 device. In all eyes, canaloplasty was concurrently with phacoemulsification. The microcatheter was inserted via a clear corneal incision and goniotomy into Schlemm's canal. The microcatheter was advanced 180 degrees, then withdrawn whilst depositing viscoelastic. This was repeated for the second 180 degrees. Glaucoma medicines were continued until the day of surgery and tapered postoperatively as warranted by IOP. |
Follow up | 12 months |
Conflict of interest/source of funding | Conflict of interest: 1 author is an employee of Sight Sciences, the manufacturer of the VISCO360 and OMNI devices. One author reports personal fees from Sight Sciences. Source of funding: Not reported. |
Analysis
Follow up issues: Of the 180 eyes that were treated, 122 had data available at 6 months, and 95 had data available at 12 months.
Study design issues: This single centre, before-and-after study reported the 12-month outcomes of ab interno canaloplasty for people with open-angle glaucoma. Cases were identified retrospectively from an analysis of patient records. As per the study design, patients were stratified by baseline IOP. In those with baseline IOP ≥18 mmHg, the primary endpoint was reduction in pressure. In those with baseline IOP <18 mmHg, the primary endpoint was medicine reduction (with maintenance of IOP).
Paired t-tests were used to evaluate differences between baseline and 12-month outcomes. p<0.05 was considered statistically significant. There was no adjustment for multiple comparisons.
Study population issues: Six eyes were from people who self-reported that they were Caucasian, 45 from people who were Black, 120 from people who were Hispanic, and 9 listed as 'other'.
Key efficacy findings
IOP reduction
Number of people analysed: 180 eyes at baseline; 122 eyes at 6 months; 95 eyes at 12 months
Follow up at time of assessment: 12 months
In people with baseline IOP of ≥18 mmHg (n=111 eyes at baseline; number at follow up not reported), there was a statistically significant decrease in IOP from 22.0 mmHg (SD 5.5 mmHg) before surgery to 15.7 mmHg (SD 4.3 mmHg) at 6 months and 17.2 mmHg (SD 5.1 mmHg) at 12 months after surgery (both p<0.0001 compared to baseline). The increase in IOP between 6 months and 12 months was not quite statistically significant (p=0.058).
In people with baseline IOP of <18 mmHg (n=69 eyes at baseline; number at follow up not reported), there was little change in IOP from 14.3 mmHg (SD 2.3 mmHg) at baseline to 15.0 mmHg (SD 3.3 mmHg) at 6 months and 15.4 mmHg (SD 4.1 mmHg) at 12 months follow up (statistical significance not reported).
Glaucoma medicine reduction
Number of people analysed: 180 eyes at baseline; 122 eyes at 6 months; 95 eyes at 12 months
Follow up at time of assessment: 12 months
In people with baseline IOP of ≥18 mmHg (n=111 eyes at baseline; number at follow up not reported), there was no change in the mean glaucoma medicine use per person from 0.9 (SD 0.9) before surgery to 1.0 (SD 0.9) at 12 months after surgery (p=0.7).
In people with baseline IOP of <18 mmHg (n=69 eyes at baseline; number at follow up not reported), there was a statistically significant decrease in the mean glaucoma medicine use per person from 1.1 (SD 0.9) at baseline to 0.6 (SD 0.6) at 12 months follow up (p<0.05).
Key safety findings
Number of people analysed: 180 eyes at baseline; 122 eyes at 6 months; 95 eyes at 12 months
Follow up at time of assessment: 12 months
Hyphaema. n=3 eyes
IOP spikes ≥10 mmHg above baseline IOP, n=2 eyes
Mild anterior chamber inflammation, n=1 eye.
Study 3 Hughes T (2020)
Study details
Study type | Single centre, before-and-after study |
Country | US |
Recruitment period | 2018 to 2019 |
Study population and number | n=64 people, 89 eyes Adults with mild to moderate open-angle glaucoma. |
Age and sex | Mean 72.1 years; 64% male |
Patient selection criteria | Inclusion criteria: Adults with mild to moderate open-angle glaucoma. Exclusion criteria: pseudoexfoliative glaucoma, pigmentary glaucoma, glaucoma associated with ocular trauma, glaucoma associated with ocular inflammation, previous incisional glaucoma surgery, and eyes with less than 90 degrees of viscodilation. |
Technique | Ab interno canaloplasty using the OMNI or VISCO360 device. In 72 eyes, canaloplasty was concurrently with phacoemulsification. The microcatheter was inserted via a clear corneal incision and goniotomy into Schlemm's canal. The microcatheter was advanced 180 degrees, then withdrawn whilst depositing viscoelastic. This was repeated for the second 180 degrees. The anterior chamber was irrigated, pressurised to physiological pressure, and injected with an antibiotic/corticosteroid. Glaucoma medicines were continued after surgery and tapered postoperatively as warranted by IOP. |
Follow up | 18 months |
Conflict of interest/source of funding | Conflict of interest: Both authors report research grants from Sight Sciences, the manufacturer of the OMNI and VISCO360 devices, for this research. Source of funding: See above. |
Analysis
Follow up issues: Of the 89 eyes assessed preoperatively, 61 had 6 month follow up data, 42 had 12 month, and 22 had 18 month.
Study design issues: This single centre, before-and-after study assessed the 18-month outcomes of ab interno canaloplasty for open-angle glaucoma. Cases were identified retrospectively from an analysis of patient records. Eyes with less than 90 degrees of viscodilation were excluded, potentially excluding people in whom the procedure was attempted but not completed. The efficacy and safety outcomes of these eyes were not reported. The primary outcomes were the difference in IOP and glaucoma medicine use from before to after surgery.
Paired t-tests were used to evaluate the differences between baseline and each postoperative timepoint for IOP and medicine use. p<0.05 was considered statistically significant. There was no adjustment for multiple comparisons.
Key efficacy findings
IOP reduction
Number of people analysed: 89 eyes at baseline, 42 at 12 months, 22 at 18 months
Follow up at time of assessment: 18 months
There was a statistically significant decrease in IOP from 24.5 mmHg (SD 8.3 mmHg) before surgery to 16.5 mmHg (SD 3.4 mmHg) at 12 months (p<0.0005) and 15.8 mmHg (SD 2.5 mmHg) at 18 months (p<0.0005).
There was no statistically significant difference in the mean change in IOP between people who had ab interno canaloplasty combined with phacoemulsification and for those people who had ab interno canaloplasty only.
Glaucoma medicine reduction
Number of people analysed: 89 eyes at baseline, 42 at 12 months, 18 at 18 months
Follow up at time of assessment: 18 months
There was a statistically significant decrease in the mean number of glaucoma medicines used from 2.5 (SD 1.3) before surgery to 1.8 (SD 1.4) at 12 months (p<0.0005) and 1.7 (SD 1.5) at 18 months (p<0.05).
There was no statistically significant difference in the change in glaucoma medicine use between people who had ab interno canaloplasty combined with phacoemulsification and for those people who had ab interno canaloplasty only.
Key safety findings
Number of people analysed: 89 eyes at baseline, 42 at 12 months, 22 at 18 months
Follow up at time of assessment: 18 months
Mild intraoperative bleeding at the surgery site with subsequent microhyphaema not considered an adverse event for this surgery. There were no clinically significant hyphaemas.
Need for future glaucoma filtering surgery, n=6
These people had higher baseline IOP and medicine use than the cohort mean.
Study 4 Ondrejka S (2019)
Study details
Study type | Single centre, before-and-after study |
Country | Germany |
Recruitment period | 2015 to 2018 |
Study population and number | n=71 people, 106 eyes Adults with mild to moderate open-angle glaucoma. |
Age and sex | Mean 75.0 years; 63% female |
Patient selection criteria | Inclusion criteria: people who had insufficiently controlled IOP on current medicine (Group 1; baseline IOP ≥18 mmHg) or, if adequately controlled, in need of reduced medicine burden (Group 2; baseline IOP <18 mmHg). Exclusion criteria: glaucoma other than primary open-angle glaucoma, prior glaucoma surgery, terminal stage of open-angle glaucoma, or central retinal vein occlusion. |
Technique | Ab interno canaloplasty using the VISCO360 device. In 94 eyes, canaloplasty was concurrently with phacoemulsification. The microcatheter was inserted via a clear corneal incision and goniotomy into Schlemm's canal. The microcatheter was advanced 180 degrees, then withdrawn whilst depositing viscoelastic. This was repeated for the second 180 degrees. The anterior chamber was then irrigated and aspirated. Glaucoma medicines were continued until the day of surgery and were then discontinued. |
Follow up | 12 months |
Conflict of interest/source of funding | Conflict of interest: The authors declared no conflict of interest. Source of funding: Sight Sciences, the manufacturer of the VISCO360 device, provided financial assistance to support writing, editorial, and statistical analysis. |
Analysis
Follow up issues: 105 eyes had data available for analysis at 12 months (SD 3 months) follow up.
Study design issues: This single centre, before-and-after study assessed the outcomes of ab interno canaloplasty in people with open-angle glaucoma. Cases were identified retrospectively from an analysis of patient records. As per the study design, patients were stratified by baseline IOP into Group 1 (baseline IOP ≥18 mmHg) and Group 2 (baseline IOP <18 mmHg). The primary outcome measure for Group 1 was change in mean IOP and mean number of glaucoma medicines at 12 months. The primary outcome for Group 2 was change in the mean number of glaucoma medicines at 12 months.
Paired t-tests with post hoc Tukey adjustment to account for multiple comparisons was done to compare IOP and the number of glaucoma medicines with baseline. p<0.05 was considered statistically significant.
Key efficacy findings
IOP reduction
Number of people analysed: 72 eyes (Group 1: baseline IOP ≥18 mmHg), 34 eyes (Group 2: baseline IOP <18 mmHg)
Follow up at time of assessment: 12 months (plus or minus 3 months)
Group 1: There was a statistically significant decrease in mean IOP from 24.6 mmHg (SD 7.1 mmHg) before surgery to 14.6 mmHg (SD 2.8 mmHg) at 12 months after surgery (p<0.001).
Group 2: There was no statistically significant change in mean IOP from before surgery to 12 months after surgery.
Glaucoma medicine reduction
Number of people analysed: 72 eyes (Group 1: baseline IOP ≥18 mmHg), 34 eyes (Group 2: baseline IOP <18 mmHg)
Follow up at time of assessment: 12 months (plus or minus 3 months)
Group 1: There was a statistically significant decrease in mean glaucoma medicine use from 2.1 (SD 1.0) before surgery to 0.2 (SD 0.6) at 12 months after surgery (p<0.001).
Group 2: There was a statistically significant decrease in mean glaucoma medicine use from 1.8 (SD 0.9) before surgery to 0.2 (SD 0.6) at 12 months after surgery (p<0.001).
Key safety findings
Number of people analysed: 106 eyes (105 at 12 months)
Follow up at time of assessment: 12 months
VISCO360 device deficiency, n=1
Catheter detached from the handle and cannula and had to be retrieved with vitrectomy forceps.
The patient had no adverse sequalae.
Hyphaema, n=14
All resolved within 7 days without the need for further intervention.
Fibrin in pupillary plane, n=1
Study 5 Toneatto G (2022)
Study details
Study type | Double-centre, before-and-after study |
Country | Italy |
Recruitment period | 2017 to 2020 |
Study population and number | n=73 people, 80 eyes Adults with mild to moderate open-angle glaucoma. |
Age and sex | Mean 74.5 years; 59% female |
Patient selection criteria | Inclusion criteria: people who had primary open angle glaucoma, pigmentary glaucoma, and pseudoexfoliative glaucoma. Exclusion criteria: not reported. |
Technique | Ab interno canaloplasty using the OMNI device. In 30 eyes, canaloplasty was concurrently with phacoemulsification. The microcatheter was inserted via a clear corneal incision and goniotomy into Schlemm's canal. The microcatheter was advanced 180 degrees, then withdrawn whilst depositing viscoelastic. This was repeated for the second 180 degrees. The anterior chamber was then irrigated and aspirated. |
Follow up | 12 months |
Conflict of interest/source of funding | Conflict of interest: The authors declared that they had no conflict of interest. Source of funding: The authors declared that external funding was not received. |
Analysis
Follow up issues: Of the 80 eyes at baseline, 66 completed the 12 months follow up.
Study design issues: This double-centre, before-and-after study assessed the outcomes of ab interno canaloplasty in people with open-angle glaucoma. Cases were identified retrospectively from an analysis of patient records. This study allowed people with pseudoexfoliative glaucoma or pigmentary dispersion glaucoma, and those who had previous glaucoma surgery. The primary outcome measures were IOP reduction and reduction in the mean number of glaucoma medicines at 12 months. Surgical success rates were also calculated. Complete successes were those who reached an IOP target no glaucoma medicine. Qualified successes were those reached an IOP target with no more glaucoma medicine use than baseline.
The mean levels of IOP at different follow up times were compared to baseline by a paired sample t-test. The decrease of glaucoma medicine use in each group was analysed by a non-parametric Wilcoxon matched-pairs signed rank test. There was no adjustment for multiple comparisons.
Study population issues: Diagnoses included primary open-angle glaucoma (63.8%), pseudoexfoliative glaucoma (33.7%), and pigmentary dispersion glaucoma (2.5%). Previous glaucoma surgeries included laser trabeculoplasty (18.8%), deep sclerectomy (12.5%), and trabeculectomy (3.8%).
Key efficacy findings
IOP reduction
Number of people analysed: 73 people, 80 eyes at baseline, 66 eyes at 12 months
Follow up at time of assessment: 12 months
There was a statistically significant decrease in mean IOP from 22.5 mmHg (SD 5.3 mmHg) before surgery to 15.0 mmHg (SD 3.6 mmHg) at 12 months after surgery (p<0.001).
In people who had canaloplasty alone, there was a statistically significant reduction in mean IOP from 23.0 mmHg (SD 5.7 mmHg) before surgery to 15.6 mmHg (SD 3.6 mmHg) at 12 months after surgery (p<0.001).
In people who had canaloplasty and cataract surgery, there was a statistically significant reduction in mean IOP from 21.5 mmHg (SD 4.7 mmHg) before surgery to 14.1 mmHg (SD 3.3 mmHg) at 12 months after surgery (p<0.001).
The difference in mean IOP decrease between groups was not statistically significant.
Glaucoma medicine reduction
Number of people analysed: 73 people, 80 eyes at baseline, 66 eyes at 12 months
Follow up at time of assessment: 12 months
There was a statistically significant decrease in mean glaucoma medicine use from 3.2 (SD 1.0) before surgery to 1.9 (SD 1.4) at 12 months after surgery (p<0.001).
In people who had canaloplasty alone, there was a statistically significant reduction in mean glaucoma medicine use from 3.0 (SD 1.1) before surgery to 2.0 (SD 1.4) at 12 months after surgery (p<0.001).
In people who had canaloplasty alone, there was a statistically significant reduction in mean glaucoma medicine use from 3.4 (SD 0.8) before surgery to 1.9 (SD 1.4) at 12 months after surgery (p<0.001).
The difference in mean glaucoma medicine use decrease between groups was not statistically significant.
Surgical success
Number of people analysed: 73 people, 80 eyes at baseline, 66 eyes at 12 months
Follow up at time of assessment: 12 months
Target IOP 16 mmHg or less and 25% or more reduction in IOP:
At 12 months, 10.3% of eyes were complete successes.
A further 43.6% of eyes were qualified successes.
Target IOP 18 mmHg or less and 25% or more reduction in IOP:
At 12 months, 11.5% of eyes were complete successes.
A further 50.0% of eyes were qualified successes.
Key safety findings
Complications
Number of people analysed: 73 people, 80 eyes at baseline, 66 eyes at 12 months
Follow up at time of assessment: 12 months
Mild or microhyphaema were not considered adverse events for this surgery.
Moderate or severe hyphema, n=2
Both cases required a wash of the anterior chamber. Both recovered within 10 days.
Mild hypotony, n=4
IOP spike of 10 mmHg or more above baseline, n=1
Further surgery, n=12
Trabeculectomy, n=9
Deep sclerectomy, n=3
Visual acuity
Number of people analysed: 73 people, 80 eyes at baseline, 66 eyes at 12 months
Follow up at time of assessment: 12 months
No statistically significant change in visual acuity was observed in people who had canaloplasty alone (p=0.31)
There was a statistically significant change in visual acuity in people who had canaloplasty and phacoemulsification from 6.8/10 (SD 2.1) before surgery to 9.1/10 (SD 2.6) at 12 months after surgery (p<0.001).
Study 6 Gillman K (2021)
Study details
Study type | Single centre, before-and-after study |
Country | Switzerland |
Recruitment period | 2015 to 2019 |
Study population and number | n=71 eyes, total people not reported Adults with mild to moderate open-angle glaucoma. |
Age and sex | Mean 73.1 years; 52% female |
Patient selection criteria | Inclusion criteria: uncontrolled mild-to-moderate open-angle glaucoma with concomitant clinically significant cataract. Exclusion criteria: not reported. |
Technique | Ab interno canaloplasty using the iTrack device. In all eyes, canaloplasty was concurrently with phacoemulsification. The microcatheter was inserted via a clear corneal incision and goniotomy into Schlemm's canal. The microcatheter was advanced 360 degrees, then withdrawn whilst depositing viscoelastic. Postoperatively, glaucoma medicine was initially withheld, then reinstated as needed to maintain IOP below 15 mmHg. |
Follow up | 12 months |
Conflict of interest/source of funding | Conflict of interest: The authors declared that they had no conflict of interest. Source of funding: The authors declared that external funding was not received. |
Analysis
Follow up issues: Of the 71 eyes identified that had ab interno canaloplasty during the study period, 54 eyes in 41 people had 12 month follow up data.
Study design issues: This single centre, before-and-after study assessed the outcomes of ab interno canaloplasty for open-angle glaucoma in combination with phacoemulsification. Cases were identified retrospectively from an analysis of patient records. Cases without 12 month follow up were excluded unless they were considered failures due to reoperation or severe complications. The primary outcome measure was IOP reduction. Surgical success rates were also calculated. Complete successes were those who had a 20% or more reduction in IOP with no medicine. Qualified successes were those who had a 20% or more reduction in IOP with no more medicine use than baseline. Failures were those who did not meet the criteria for success, or those who had additional glaucoma surgery or loss of light perception.
The cumulative probability of success was assessed using Kaplan-Meier survival curves. The tests were 2-tailed. p<0.05 was considered statistically significant. There was no adjustment for multiple comparisons.
Study population issues: All included people were Caucasian. Diagnoses included primary open-angle glaucoma (66.7%), pseudoexfoliative glaucoma (18.5%), and pigmentary glaucoma (14.8%). A total of 4 eyes had previous glaucoma surgery.
Key efficacy findings
Number of people analysed: 41 people, 54 eyes
Follow up at time of assessment: 12 months
There was a statistically significant decrease in mean IOP from 23.6 mmHg (SD 7.4 mmHg) before surgery to 14.2 mmHg (SD 2.9 mmHg) at 12 months after surgery (p<0.001).
Glaucoma medicine reduction
Number of people analysed: 41 people, 54 eyes
Follow up at time of assessment: 12 months
There was a statistically significant decrease in mean glaucoma medicine use from 2.9 (SD 1.0) before surgery to 0.6 (SD 1.1) at 12 months after surgery (p<0.001).
Surgical success
Number of people analysed: 41 people, 54 eyes
Follow up at time of assessment: 12 months
Complete success was achieved in 46% of eyes, with a further 19% achieving qualified success.
Failure was seen in 35% of eyes, all due to uncontrolled IOP, 36.8% of which required further filtering surgery.
Key safety findings
Number of people analysed: 41 people, 54 eyes
Follow up at time of assessment: 12 months
Self-resolving hyphaema was not considered an adverse event.
Complications up to 30 days after surgery:
IOP spikes over 30 mmHg, n=12
Self-resolving endothelial blood stain, n=1
Iris atrophy, n=1
Pupillary block, n=1
Fibrin plug, n=1
Complications from 1 month after surgery onwards:
IOL subluxation, n=1
Additional glaucoma surgery, n=7
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