YAG Vitreolysis for Floaters
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|ClinicalTrials.gov Identifier: NCT02897583|
Recruitment Status : Completed
First Posted : September 13, 2016
Last Update Posted : September 13, 2016
|Condition or disease||Intervention/treatment||Phase|
|Weiss Ring Floaters Posterior Vitreous Detachment||Procedure: YAG vitreolysis||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Prospective Randomized Controlled Trial Evaluating the Safety and Efficacy of YAG Vitreolysis Versus Sham for Symptomatic Weiss Ring Due to Posterior Vitreous Detachment|
|Study Start Date :||February 2015|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||August 2016|
Experimental: YAG vitreolysis
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.
Procedure: YAG vitreolysis
Sham Comparator: Sham YAG vitreolysis
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.
Procedure: YAG vitreolysis
- Subjective improvement in floater symptoms [ Time Frame: 6 Months ]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?"
- Best Corrected Visual Acuity [ Time Frame: 6 Months ]Mean change in visual acuity from Baseline as measured by ETDRS vision testing at 6 months
- VFQ-25 Near Activities [ Time Frame: 6 Months ]Mean change in baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) near activities subscale
- VFQ-25 Distance Activities [ Time Frame: 6 Months ]Mean change in baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) distance activities subscale
- Qualitative changes on infrared and color photography [ Time Frame: 6 Months ]Qualitative changes on infrared and color photography
- Incidence and severity of ocular and systemic adverse events [ Time Frame: 6 Months ]Incidence and severity of ocular and systemic adverse events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02897583
|Principal Investigator:||Chirag P Shah, MD, MPH||Attending Physician|