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Study evaluating the safety and efficacy of YAG laser for the treatment of vitreous opacity

Efficacy and safety of YAG laser vitreolysis for symptomatic posterior vitreous detachment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12191616
Enrollment
400
Registered
2022-10-13
Start date
2019-10-08
Completion date
Unknown
Last updated
2022-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment of symptomatic posterior vitreous detachment via YAG laser vitreolysis. Eye Diseases

Interventions

Randomization was achieved by employing a random number for each patient, 1 for treatment and 2 for control. Patients in treatment group will be dilated with phenylephrine 2.5% and tropicamide 1% and

Sponsors

Harbin Aier Eye Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 14/11/2022: 1. Symptomatic vitreous opacities owing to complete PVD (Weiss ring), symptoms for at least 3 months 2. No sensation of flashing for at least 2 weeks 3. Clear optical media 4. The distance between floaters and retina or lens was over 3mm (measured by B-scan ultrasound) 5. The 10-point visual disturbance score of at least 4 6. Ability to undertake YAG laser procedure 7. Acceptance of related risks _____ Previous inclusion criteria: 1. Symptomatic vitreous opacities owing to complete PVD (Weiss ring), symptoms for at least 3 months 2. Clear optical media 3. The distance between floaters and retina or lens was over 3mm (measured by B-scan ultrasound) 4. The 10-point visual disturbance score at least 4 5. Ability to undertake YAG laser procedure 6. Acceptance of related risks

Exclusion criteria

Exclusion criteria: Current exclusion criteria as of 11/11/2022: 1. Snellen BCVA was worse than 20/50 2. Patients with a history of glaucoma, severe cataract, vitreous hemorrhage, retinal disease, macular disease. _____ Previous exclusion criteria as of 18/10/2022: 1. Snellen BCVA was worse than 20/50 2. Less than 50% of the Weiss ring was ablated after one treatment (objective changes were evaluated by the surgeon who performed the YAG laser vitreolysis); patients with a history of glaucoma, severe cataract, vitreous hemorrhage, retinal disease, macular disease. _____ Previous exclusion criteria: 1. Snellen BCVA was worse than 20/50 2. Eyes with intraocular lens (IOL) 3. Less than 50% of the Weiss ring was ablated after one treatment (objective changes were evaluated by the surgeon who performed the YAG laser vitreolysis); patients with a history of glaucoma, severe cataract, vitreous hemorrhage, retinal disease, macular disease.

Design outcomes

Primary

MeasureTime frame
At preoperative, postoperative week 1, month 1, month 3 and month 6: 1. Visual disturbance measured using a 10-point visual disturbance score (with 0 being asymptomatic and 10 indicating impairing symptoms) 2. Degree of patients disturbed by floaters measured using a short questionnaire of 4-degree floater symptoms 3. Symptoms improvement percentage measured using a 4-level qualitative scale

Secondary

MeasureTime frame
At preoperative, postoperative week 1, month 1, month 3 and month 6: 1. The National Eye Institute Visual Functioning Questionnaire 25 (NEI VFQ-25) 2. Best corrected visual acuity (BCVA)

Countries

China

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026