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

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)

Study Overview

• Status: Unknown
• Conditions: Macular Holes
• Intervention / Treatment: Procedure: Conventional ILM Peeling; Procedure: Inverted ILM Peeling

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mauricio Maia, MD, PhD; Phone Number: +55-18-991137727; Email: maiamauricio@terra.com.br
• Study Contact Backup: Name: Luci p Silva, PhD, MBA; Phone Number: 11971571967; Email: luci.pesquisa@gmail.com

Study Locations

• Brazil
  • São Paulo, Brazil, 04023-062
    • Recruiting
    • Dept. of Ophthalmology
    • Contact: Luci p Silva, PhD, MBA; Phone Number: 11971571967; Email: luci.pesquisa@gmail.com
    • Contact: Mauricio Maia, MD, PhD; Phone Number: 2265 1155764848; Email: maiamauricio@terra.com.br
    • Principal Investigator: Luiz Felipe A Lucatto, MD
    • Sub-Investigator: Octaviano Magalhães Júnior, PhD, MD
    • Sub-Investigator: Felipe Muralha, MD
    • Sub-Investigator: Alex Grupenmacher, MD
    • Sub-Investigator: Francisco Stefanini, MD
    • Sub-Investigator: Muller G Urias, MD
    • Principal Investigator: Maia Mauricio, PhD, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A: Conventional ILM peeling; peeling with complete removal of the internal limiting membrane (ILM)	Procedure: Conventional ILM Peeling; peeling with complete removal of the internal limiting membrane (ILM)
Active Comparator: GroupB: 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Anatomic closure	Rate of anatomic macular hole closure in the OCT at month 6	Month 6 post operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BCVA mean	mean best corrected visual acuity (BCVA) at month 6	Month 6 post operative
BCVA change	change in the BCVA at month 6	Screening and Month 6 post operative
Integrity Membrane measured in microns (μm) by OCT	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	Month 6 post operative

Collaborators and Investigators

• Sponsor: Federal University of São Paulo
• Investigators: Study Director: Mauricio Maia, MD, PhD, Federal University of São Paulo

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2018
• Primary Completion (Anticipated): June 15, 2020
• Study Completion (Anticipated): June 30, 2020

Study Registration Dates

• First Submitted: March 21, 2019
• First Submitted That Met QC Criteria: March 22, 2019
• First Posted (Actual): March 25, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2019
• Last Update Submitted That Met QC Criteria: March 22, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: macular holes
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Perforations
• Other Study ID Numbers: IMH2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No