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

Macular Holes Clinical Trial

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

Status Recruiting

Clinical Trial 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)

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Macular Holes
• Retinal Perforations

• NCT number: NCT03888625
• Study type: Interventional
• Source: Federal University of São Paulo
• Contact: Mauricio Maia, MD, PhD
• Phone: +55-18-991137727
• Email: maiamauricio@terra.com.br
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2018
• Completion date: June 30, 2020