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

Federal University of São Paulo

Status: Unknown

Conditions: Macular Holes

Treatments: Procedure: Inverted ILM Peeling; Procedure: Conventional ILM Peeling

Study type: Interventional

Funder types: Other

Identifiers

NCT03888625

IMH2019

Details and patient eligibility

About

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)

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Group A: Conventional ILM peeling

Active Comparator group

Description:

peeling with complete removal of the internal limiting membrane (ILM)

Treatment:

Procedure: Conventional ILM Peeling

GroupB: Inverted ILM Peeling

Active Comparator group

Description:

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

Treatment:

Procedure: Inverted ILM Peeling