UHR-OCT and HD-OCT for Preretinal Membranes: Is There a Difference Between ICG and Membrane Blue? A Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- UHR-OCT HD-OCT
Study Overview
Brief Summary
Using the UHR-OCT and HD-OCT to evaluate early postoperative changes in patients with diagnosis preretinal membrane after successfully performed pars-plana vitrectomy and membrane peeling with two different types of dyes.
Detailed Description
Surgical procedures performed are pars-plana vitrectomy and membrane peeling with or without cataract extraction and IOL implantation. The type of the dyes is randomized. The study is designed to include a total of tweny cases (10 cases with ICG and 10 cases with Membrane blue)
Main outcome measures are:
UHR-OCT, HD-OCT distance and near visual acuity and contrast sensitivity amsler grid secondary outcome measures are: OCT Stratus 3000 and visual field. Clinical examinations: preoperative, and follow-up examinations after 1 week, 1 months, 3 months, 6 months and 12 months.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Preretinal membrane
- •Age between 18 and 85 years
- •Combined surgery possible(phacoemulsification and vitreoretinal procedure)
Exclusion Criteria
- •Age-related macular degeneration
- •Previous retinal detachment surgery
- •Previous laser treatment
Outcomes
Primary Outcomes
UHR-OCT HD-OCT
Time Frame: 12 months
Distance Visual acuity
Time Frame: 12 months
Near Visual acuity
Time Frame: 12 months
Contrast sensitivtiy
Time Frame: 12 months
Secondary Outcomes
- OCT Stratus 3000(12 months)
- Visual Field(12 months)