Compare the Healing Process of Idiopathic Macular Hole With Different Surgical Techniques

Not Applicable

• Conditions: Macular Holes
• Interventions: Procedure: Conventional ILM Peeling; Procedure: Inverted ILM Peeling

• Registration Number: NCT03888625
• Lead Sponsor: Federal University of São Paulo

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.

Study Timeline

• Study Start: 2018-06-15
• Status Verified: 2019-03
• Study First Submitted: 2019-03-21
• Study First Submitted QC: 2019-03-22
• Last Update Submitted: 2019-03-22
• Study First Posted: 2019-03-25
• Last Update Posted: 2019-03-25
• Primary Completion: 2020-06-15
• Study Completion: 2020-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A: Conventional ILM peeling	Conventional ILM Peeling	peeling with complete removal of the internal limiting membrane (ILM)
GroupB: Inverted ILM Peeling	Inverted ILM Peeling	the inverted ILM peeling technique, in which the ILM is left in the edge of the macular hole and the free area is inverted over the macular hole before fluid-air exchange

Primary Outcome Measures

Name	Time	Method
Rate of Anatomic closure	Month 6 post operative	Rate of anatomic macular hole closure in the OCT at month 6

Secondary Outcome Measures

Name	Time	Method
BCVA mean	Month 6 post operative	mean best corrected visual acuity (BCVA) at month 6
BCVA change	Screening and Month 6 post operative	change in the BCVA at month 6
Integrity Membrane measured in microns (μm) by OCT	Month 6 post operative	In the month 6, the area of discontinuity of the perifoveal external limiting membrane and ellipsoid zone in the OCT images will be measured in microns (μm) and correlated between groups

Trial Locations

Locations (1)

Dept. of Ophthalmology; 🇧🇷 São Paulo, Brazil