NCT03888625

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

Randomized Clinical Trials to Compare the Healing Process of Idiopathic Macular Hole With Different Surgical Techniques

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Federal University of São Paulo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Macular Holes

Interventions

Type	Name	Description
PROCEDURE	Conventional ILM Peeling	peeling with complete removal of the internal limiting membrane (ILM)
PROCEDURE	Inverted ILM Peeling	the inverted ILM peeling technique - the technique of Inverted flap described by Michalewska, 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

Timeline

• Start date: 2018-06-15
• Primary completion: 2020-06-15
• Completion: 2020-06-30
• First posted: 2019-03-25
• Last updated: 2019-03-25

Locations

1 site across 1 country: Brazil