An interventional study of Hydrated Amniotic Membrane Plug and ILM filling in Macular Holes, sponsored by Oriental Neurosurgery Evidence-Based-Study Team. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-31.
Sponsored by Oriental Neurosurgery Evidence-Based-Study Team · Not applicable, Interventional, and Treatment
To compare anatomic and functional results, and to evaluate postoperatively the healing process in 3 different techniques for the closure of the refractory macular holes (MH).
The aim of the study is to evaluate the therapeutic efficacy of Hydrated Amniotic Membrane in promoting closure of refractory macular holes.
The Hydrated Amniotic Membrane has been used in some cases as an adjunct in the macular holes closure and as a substrate for cell growth and improvement of visual acuity. Hydrated Amniotic Membrane is supposed to promote epithelialization and have anti-fibrotic, anti-inflammatory properties.
In the present study, the patients who meet the inclusion criteria will be randomized and undergo pars plana vitrectomy surgery with peeling of the ILM and a fragment of the ILM itself or an amniotic membrane plug will be put in place.
The patients included in the study will undergo a complete eye examination, including corrected Visual Acuity measurement (BCVA), performing the Optical Coherence Tomography (OCT) and/or microperimetry, multifocal electroretinogram (mfERG) in the pre-operative. Patients will undergo surgery after complementary exams and adequate pre-anesthetic evaluation.
Patients will be evaluated on the 1st and 7th postoperative days and at 1, 3, and 6 months after surgery. The patient will undergo a complete eye examination and postoperative follow-up as described above, and during visits on the 1st and 7th day, and in the 1st, 3th and 6th month of the postoperative period, BCVA and OCT will be performed and/or the microperimetry, multifocal electroretinogram (mfERG) will be performed in the 1st, 3th and 6th postoperative month for evaluation and monitoring of anatomical and functional responses, respectively.
139 studies on the registry are indexed under Retinal Perforations; 22 are open to participants now.
This study's planned enrollment of 80 is above the median of 50 across 94 interventional studies indexed under Retinal Perforations.
Browse Retinal Perforations studies →Oriental Neurosurgery Evidence-Based-Study Team is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients who meet any of 1/2 and signed can be included. Note: if both eyes of the subject meet the inclusion criteria, the investigator decides which eye should be included.
Exclusion Criteria:
Known to be allergic to amniotic membrane.
Patients with any of the following eye diseases:
History of vitreoretinal surgery for a condition other than the idiopathic macular hole (retinal detachment, vitreous hemorrhage);
Patients with any of the following eye conditions:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients suffering from refractory macular holes as documented by spectral-domain OCT will undergo pars plan vitrectomy with Hydrated Amniotic Membrane insertion into the macular hole.
Procedure: Hydrated Amniotic Membrane Plug
The ILM filling technique, in which free ILM is plug into the macular hole area
Procedure: ILM filling
Peeling with complete removal of the internal limiting membrane within the vascular arch
Procedure: Conventional ILM peeling
Using Hydrated Amniotic Membrane plug with vitrectomy to try to close refractory macular hole
The ILM filling technique - Rossi et al show that ILM filling technique was more efficacious in closing full-thickness macular holes larger than 630μm, in which the free ILM after peeling is plug into the area of the macular hole
Peeling with complete removal of the internal limiting membrane within the vascular arch
Rate of Anatomic closure
Rate of anatomic macular hole closure in the OCT at month 6
Time frame: Month 6 post operative
Reconstruction of the foveal layered retinal structure change
Change in the reconstruction of the foveal layered retinal structure by OCT at 1, 3, and 6 months
Time frame: Month 1, 3, 6 post-operative
amniotic membrane dislocation
conform amniotic membrane dislocation in the OCT and/or binocular indirect ophthalmoscope at day 1 and 7
Time frame: DAY 1,7 post operative
BCVA change
change in the BCVA at Preoperative,1, 3, and 6 months
Time frame: Time Frame: Preoperative,Month 1, 3, 6 post operative
Retinal capillary plexus density change
change in the retinal capillary plexus density with OCT-A at Preoperative,1, 3, and 6 months
Time frame: Preoperative,Month 1, 3, 6 post operative
Start is estimated for Jun 2022; primary completion for May 2024, 23 months later.
Of 45 non-industry interventional studies with no phase under Retinal Perforations, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 31. This study's planned 23 months is below that.
Counting every sponsor, half of 45 studies reached it within 28 months; a quarter within 12 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
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Oriental Neurosurgery Evidence-Based-Study Team