Safety summary

Retinal tear and detachment

Retinal tear was reported in 3 people who had YAG laser vitreolysis in the case series of 34 people (34 eyes; Shah 2020). These events were evident at 1.4 years to 2.8 years.

Retinal tear was reported in 1 person and retinal detachment in 2 people in a review of 16 complications voluntarily reported to the American Society of Retina Specialists Research and Safety in Therapeutics Committee during a 6-month period (Hahn 2017).

Retinal haemorrhage

Mild retinal haemorrhage was reported in 1 person (1 eye) in the case series of 50 people (55 eyes). The person had previous severe floaters and PVD, and was then given glucocorticoid, ocular nerve nutrient and vitamin C for 2 weeks. This event subsequently resolved (Sun 2019).

Laser injury-related transient posterior pole retinal haemorrhage was described in 2 people in the review of 16 complications. Of these events, 1 person remained asymptomatic, while the other person had a transient scotoma that lasted a few weeks and corresponded to the area of subretinal haemorrhage with nearby retinal whitening (Hahn 2017).

Intraocular pressure (IOP), ocular hypertension and secondary glaucoma

The mean IOP increased from 14.1 mmHg (SD 3.6) at baseline to 14.5 mmHg (SD 3.0; p=0.841) at 6-month follow up in the YAG laser vitreolysis group, and decreased from 15.9 mmHg (SD 1.7) to 15.3 mmHg (SD 1.7; p=0.992) in the sham group in the randomised controlled trial of 21 people (21 eyes). There was no statistically significant difference between the 2 groups at baseline or 6 months (all p>0.05; Ludwig 2021).

No statistically significant change in IOP was found at a mean follow up of 2.3 years from baseline (difference, -0.09 mmHg; 95% CI -1.2 to 1.0; p=0.88) in the case series of 34 people (34 eyes). In the same study, bilateral ocular hypertension was observed in 1 person at 0.6 years after 1 session of unilateral YAG laser vitreolysis (Shah 2020).

The mean IOP changed from 15.71 mmHg (SD 2.4) at baseline to 15.34 mmHg (SD 3.27) at 6 months after YAG laser vitreolysis (p=0.23) in the case series of 50 people (55 eyes; Sun 2019).

Temporary ocular hypertension developed in 2 people in the case series of 34 people (34 eyes). The IOP was controlled to normal IOP levels with ocular hypotensive medications (Garcia 2021).

Prolonged elevation of the IOP was described in 5 people in the review of 16 complications. Of these 5 cases, 3 resulted in secondary glaucoma, and trabeculectomy was needed in 2 of these cases (Hahn 2017).

Worsening of vision and symptoms

Temporary blurred vision during the first hour after YAG laser vitreolysis was reported in 5 people in the randomised controlled trial of 21 people (21 eyes). These cases spontaneously resolved on the first day (Ludwig 2021).

Worse visual quality was reported in 3 people in the case series of 51 people (51 eyes). These people complained of more tiny asteroid floaters or floater remnants (Lin 2021).

Worsening of floaters was described in 3 people during a mean follow up of 2.3 years in the case series of 34 people (34 eyes). Of the 3 people, 1 person had a pars plana vitrectomy and the symptoms were 100% improved at 1.5 years after surgery, without any complications (Shah 2020).

Worsening of symptoms was reported in 1 person (1 eye) in the case series of 50 people (55 eyes; Sun 2019).

An increased number of symptomatic floaters was seen in 1 person in the review of 16 complications (Hahn 2017).

Other complications

Anterior and intermediate uveitis was reported in 1 person at 0.9 years after a single laser session in the case series of 34 people (34 eyes; Shah 2020).

Focal cataract was described in 5 people (5 eyes) in the review of 16 complications. Of these events, 3 focal cataracts were within the visual axis and 2 had associated posterior capsule rupture (Hahn 2017).

One posterior chamber intraocular lens was pitted peripherally with the YAG laser in the randomised controlled trial of 52 people (52 eyes). This happened when anterior floaters were treated, although this finding was not visually significant (Shah 2017).

Anecdotal and theoretical adverse events

In addition to safety outcomes reported in the literature, professional experts are asked about anecdotal adverse events (events that they have heard about) and about theoretical adverse events (events that they think might possibly occur, even if they have never happened).

For this procedure, professional experts listed the following additional anecdotal or theoretical adverse events: induced inflammation, retinal contusion, retinal damage, and lens damage.