Randomized Clinical Trials to Compare the Healing Process of Idiopathic Macular Hole With Different Surgical Techniques
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Macular Holes
- Sponsor
- Federal University of São Paulo
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Rate of Anatomic closure
- Last Updated
- 7 years ago
Overview
Brief Summary
To compare anatomic and functional results, and to evaluate postoperatively the healing process in 2 different techniques for the closure of the macular holes (MH)
Detailed Description
Patients with macular holes classified in stages 3 and 4 will be randomized into 2 groups. . In Group A, patients will undergo peeling with complete removal of the internal limiting membrane (ILM) and in the group B, the inverted ILM peeling technique will be performed. The 20% sulfur hexafluoride (SF6) gas will be used as a tamponade agent in all surgeries, and patients will be instructed to avoid the prone position for 5 days. OCT images will be performed in the first 5 postoperative days and months 1, 3 and 6. The primary outcome is anatomic closure of the MH closure in the month 6. The second outcomes are: mean best corrected visual acuity (BCVA) at month 6, mean change in the BCVA at month 6; integrity of the perifoveal external limiting membrane and ellipsoid zone on Optical Coherence Tomography (OCT); MH closure rate over time in days; functional improvement of microperimetry Statistical analysis will be performed with Student t-test and the p-value of ≤ 0.05 is considered significant.
Investigators
Mauricio Maia
Professor of Ophthalmology Dept
Federal University of São Paulo
Eligibility Criteria
Inclusion Criteria
- •\> Stage 3 and 4 macular holes with visual acuity between 20/30 and 20/800 according to the ETDRS chart.
Exclusion Criteria
- •Macular holes secondary to ocular trauma, myopia or retinal detachment
- •Any previous treatment for the macular hole
- •Evidence on examination of any diabetic retinopathy
- •History or presence of wet or dry age macular degeneration (AMD)
- •Presence of epiretinal membrane or prior uveitis
- •Any ocular surgery within 3 months before baseline
- •Intra or periocular infection
Outcomes
Primary Outcomes
Rate of Anatomic closure
Time Frame: Month 6 post operative
Rate of anatomic macular hole closure in the OCT at month 6
Secondary Outcomes
- BCVA mean(Month 6 post operative)
- BCVA change(Screening and Month 6 post operative)
- Integrity Membrane measured in microns (μm) by OCT(Month 6 post operative)