Clinical Trials Logo
  1. Home
  2. Macular Holes
  3. NCT05396209

To Evaluate the Therapeutic Efficacy of Hydrated Amniotic Membrane in Promoting Closure of Refractory Macular Holes.

Macular Holes Clinical Trial

Official title:
Multicenter Case Control Clinical Trials to Compare the Healing Process of Refractory Macular Hole With Different Surgical Techniques

Clinical Trial Summary

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).

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05396209
Study type Interventional
Source Oriental Neurosurgery Evidence-Based-Study Team
Contact Qihua Wang, MD
Phone 86-10-18601180961
Email wqha01696@btch.edu.cn
Status Recruiting
Phase N/A
Start date June 1, 2022
Completion date June 15, 2025
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT03713268 - Intraoperative OCT Guidance of Intraocular Surgery II
Completed NCT04535622 - Efficacy of Exercise Program for Facedown Posture-related Pain After Retinal Surgery N/A
Completed NCT03572725 - Air Tamponade and Non-supine Positioning in Macular Hole Surgery. N/A
Completed NCT01471912 - Elongation of Foveal Tissue After Macular Hole Surgery N/A
Completed NCT03646695 - ILM Flap Transposition Versus ILM Peeling for Macular Holes: a Pilot Study N/A
Completed NCT06323902 - Autologous Platelet-rich Plasma as a Treatment for Macular Holes
Completed NCT01974310 - Postoperative Positioning After Surgery for Macular Holes N/A
Completed NCT00537992 - Blue-Blocking IOLs in Combined Surgery N/A
Completed NCT05171621 - Measuring Subjective Quality of Vision and Metamorphopsia Before and After Epiretinal Membrane and Macular Hole Surgery
Recruiting NCT06000111 - Duration of Face Down Positioning for Full-Thickness Macular Hole Repair N/A
Recruiting NCT04135638 - Inverted ILM-flap Techniques Variants for Macular Hole Surgery: Outcomes Comparison N/A
Completed NCT03525899 - Macular Hole After Diabetic Vitrectomy
Completed NCT03917602 - Human Amniotic Membrane Plug for Large Macular Holes N/A
Completed NCT04527848 - Comparison of Two Intraocular Gas Injection Techniques in Macula Hole Surgery Phase 4
Recruiting NCT04116892 - Comparative Analysis of Large Macular Hole Surgeries N/A
Completed NCT01229657 - Evaluation of Anatomic and Visual Outcomes of Initially Closed Macular Holes N/A
Completed NCT01381965 - Foveal Cone Outer Segment Resumption to Predict Visual Recovery After Macular Hole Surgery N/A
Completed NCT01306487 - Observation of Recovery of Foveal Cone Microstructures After Macular Hole Surgery N/A
Completed NCT03174639 - High Myopia Macular Hole and Retinal Detachment Treated With Double ILM Flaps N/A
Recruiting NCT05083650 - Large Macular Hole Closure Rate With Amniotic Membrane Graft With and Without Limitorrhexis N/A