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This is a single-center, prospective randomized controlled trial evaluating the safety and efficacy of YAG vitreolysis versus sham for symptomatic Weiss ring due to posterior vitreous detachment.
52 subjects will be enrolled in the trial and randomized in a 2:1 ratio to receive either YAG laser vitreolysis or sham laser for symptomatic Weiss ring due to posterior vitreous detachment. Subjects will follow up at one week, one month, three months, and six months after the procedure. Assessments will include a questionnaire regarding duration of floater symptoms prior to presentation, severity of floater symptoms, number of floaters, and activity most inconvenienced by presence of floaters; Medical, ocular history and demographics collected; ETDRS and Snellen visual acuity; Optos color photography; Heidelberg Spectralis Optical Coherence Tomography (OCT) and infrared photo; B scan ultrasound of Weiss ring with caliper measurement of nearest distance between Weiss ring and retina, Weiss ring and posterior lens capsule (only in phakic eyes); Slit lamp and indirect ophthalmoscopy with scleral depression of study eye; Applanation tonometry; Visual Functioning Questionnaire-25 (VFQ 25). Qualitative change in Optos photography will evaluated by a masked physician.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YAG vitreolysis | Experimental | A Karickoff lens with goniosol will be used to perform the YAG vitreolysis. The number of shots will be determined at the discretion of the treating physician. A focus offset may be used at investigator discretion. Single shot mode will be used. The maximum energy per pulse will be 7 mJ. The endpoint of treatment is the vaporization of the Weiss ring into gas, as well as the disruption of it into smaller fragments as well as any other vitreous opacities deemed visually significant by the treating physician. Only one treatment session will be performed. |
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| Sham YAG vitreolysis | Sham Comparator | Sham laser treatment will be applied under the same procedure used for laser treatment but by turning the laser power down to 0.3 mJ and using a separate lens covered by a filter that absorbs the power, so no laser enters the eye. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YAG vitreolysis | Procedure |
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| Measure | Description | Time Frame |
|---|---|---|
| Subjective improvement in floater symptoms | Questionnaire which asks: "Please rate your visual disturbance by the floaters on a 0-10 scale, with 0 being no symptoms to 10 being debilitating symptoms," "Please quantify your post-operative improvement as a percentage," and "How would you describe your floaters today compared to right before the laser procedure?" | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Best Corrected Visual Acuity | Mean change in visual acuity from Baseline as measured by ETDRS vision testing at 6 months | 6 Months |
| VFQ-25 Near Activities | Mean change in baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) near activities subscale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chirag P Shah, MD, MPH | Attending Physician | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28727887 | Derived | Shah CP, Heier JS. YAG Laser Vitreolysis vs Sham YAG Vitreolysis for Symptomatic Vitreous Floaters: A Randomized Clinical Trial. JAMA Ophthalmol. 2017 Sep 1;135(9):918-923. doi: 10.1001/jamaophthalmol.2017.2388. |
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| ID | Term |
|---|---|
| C000726608 | vitreous floaters |
| D020255 | Vitreous Detachment |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| 6 Months |
| VFQ-25 Distance Activities | Mean change in baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) distance activities subscale | 6 Months |
| Qualitative changes on infrared and color photography | Qualitative changes on infrared and color photography | 6 Months |
| Incidence and severity of ocular and systemic adverse events | Incidence and severity of ocular and systemic adverse events | 6 Months |