An interventional study of Conventional ILM Peeling and Inverted ILM Peeling in Macular Holes, sponsored by Federal University of São Paulo. Status unknown at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-25.
Sponsored by Federal University of São Paulo · Not applicable, Interventional, and Treatment
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)
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.
156 studies on the registry are indexed under Retinal Perforations; 21 are open to participants now.
This study's planned enrollment of 60 is above the median of 44 across 104 interventional studies indexed under Retinal Perforations.
Browse Retinal Perforations studies →Federal University of São Paulo is the lead sponsor of 427 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
> Stage 3 and 4 macular holes with visual acuity between 20/30 and 20/800 according to the ETDRS chart.
Exclusion Criteria:
peeling with complete removal of the internal limiting membrane (ILM)
Procedure: Conventional 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
peeling with complete removal of the internal limiting membrane (ILM)
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
Rate of Anatomic closure
Rate of anatomic macular hole closure in the OCT at month 6
Time frame: Month 6 post operative
BCVA mean
mean best corrected visual acuity (BCVA) at month 6
Time frame: Month 6 post operative
BCVA change
change in the BCVA at month 6
Time frame: 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
Time frame: Month 6 post operative
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Federal University of São Paulo