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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03888625
• Other study ID #: IMH2019
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2018
• Est. completion date: June 30, 2020

Study information

• Verified date: March 2019
• Source: Federal University of São Paulo
• Contact: Mauricio Maia, MD, PhD
• Phone: +55-18-991137727
• Email: maiamauricio[@]terra.com.br
• Is FDA regulated: No
• Study type: Interventional

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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 30, 2020
• Est. primary completion date: June 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Macular Holes
• Retinal Perforations

Intervention

Procedure:
• Conventional ILM Peeling
peeling with complete removal of the internal limiting membrane (ILM)
• 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

Locations

Country	Name	City	State
Brazil	Dept. of Ophthalmology	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Anatomic closure	Rate of anatomic macular hole closure in the OCT at month 6	Month 6 post operative
Secondary	BCVA mean	mean best corrected visual acuity (BCVA) at month 6	Month 6 post operative
Secondary	BCVA change	change in the BCVA at month 6	Screening and Month 6 post operative
Secondary	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