An interventional study of Pars plana Vitrectomy with internal limiting membrane peeling in Macular Holes, sponsored by Hospital Oftalmologico de Sorocaba. Active, not recruiting at 2 sites in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-06.
Sponsored by Hospital Oftalmologico de Sorocaba · Not applicable, Interventional, and Treatment
Prospective, randomized, unmasked interventional study. To evaluate anatomical and functional results through microperimetry in cases of refractory or large macular holes (MH), using amniotic membrane (AM) or internal limiting membrane ( ILM ).
This study will evaluate functional outcomes through microperimetry in patients undergoing macular hole surgery. It will focus on patients with macular holes ≥600 microns, as well as those with holes refractory to conventional surgical treatment. The study will assess the use of amniotic membrane or internal limiting membrane (ILM) as adjuncts in the macular hole closure process.
The gold-standard treatment for idiopathic macular holes is pars plana vitrectomy (PPV), which involves removal of the posterior hyaloid (when adhered) and the ILM using a vital dye, followed by placement of buffering gas (C3F8 or SF6) at a non-expandable concentration. However, approximately 44% of large macular holes remain unclosed after conventional surgery.
To improve closure rates in such cases, new techniques have been introduced, including the inverted ILM flap technique and the free ILM flap technique. While studies demonstrate the effectiveness of these techniques, they show no significant improvement in visual function.
The amniotic membrane (AM) has recently been explored as an adjunct for macular hole closure and as a substrate for cell growth and visual acuity improvement. Amniotic membranes are believed to promote epithelialization and possess anti-fibrotic, anti-inflammatory, anti-angiogenic, and antimicrobial properties.
In this study, eligible patients will be randomized into two groups:
Once the AM plug or ILM flap is confirmed in its correct location, a fluid-gas exchange will be performed with 12.5% C3F8 buffering gas, and patients will maintain a face-down position for 7 days postoperatively.
Patients included in the study will undergo:
The use of the amniotic membrane, given its anti-inflammatory, anti-fibrotic, and cell growth-supporting properties, is expected to increase closure rates in refractory and large macular holes and contribute to better functional outcomes by supporting outer retinal layer regeneration.
The Sorocaba Eye Bank (BOS) will provide, prepare, and preserve the amniotic membrane used in this study.
139 studies on the registry are indexed under Retinal Perforations; 22 are open to participants now.
This study's enrollment of 23 is below the median of 50 across 94 interventional studies indexed under Retinal Perforations.
Browse Retinal Perforations studies →Hospital Oftalmologico de Sorocaba is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Patients who will be treated with a amniotic membrane plug
Device: Pars plana Vitrectomy with internal limiting membrane peeling
patients who will be treated with a internal limiting membrane flap
Device: Pars plana Vitrectomy with internal limiting membrane peeling
The pars plana 23-gauge (23G) vitrectomy technique will be performed with removal of the internal limiting membrane (ILM) (when adhered to the macula) and placement of either an amniotic membrane plug or an ILM flap in the macular hole. This will be followed by a fluid-air exchange and buffering gas infusion (12.5% C3F8). The amniotic membrane plug will be prepared using a dermatological punch with a diameter of 1 to 2 mm, depending on the size of the macular hole as measured by OCT. It will be positioned inside the macular hole using 23G forceps, with its chorionic side facing the retinal pigmented epithelium (RPE). The ILM flap will be created at the time of peeling-with an inverted flap in primary cases and a free flap in refractory cases. It will be positioned over the hole (inverted flap) or inside the macular hole (free flap) using 23G ILM forceps. These techniques will be assisted by the use of an extra lighting sclerotomy.
Also known as: Use of Amniotic membrane plug, Use of a internal limiting membrane inverted flap, gas tamponade (C3F8 12,5%)
The retinal sensitivity
measured by the microperimetry
Time frame: through study completion, an average of 1 year
The fixation stability
measured by the microperimetry
Time frame: through study completion, an average of 1 year
the macula hole closure rate
measured by OCT
Time frame: through study completion, an average of 1 year
Plan to share: No — Only the microperimetry graphs and OCT images will be published, without any IPD.
This study is active, not recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Hospital Oftalmologico de Sorocaba