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Macular Holes clinical trials

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NCT ID: NCT06433284 Not yet recruiting - Macular Holes Clinical Trials

Comparative Study of Decellularized Human Amniotic Membrane Hydrogel and Inverted Internal Limiting Membrane Flap in Idiopathic Large Macular Holes

MACROHOLE
Start date: January 1, 2025
Phase: N/A
Study type: Interventional

The human amniotic membrane (hAM) patch, introduced by Rizzo et al. in 2018, showed a 100% anatomical success rate for large or failed macular holes over a 6-month follow-up. Despite its regenerative properties like promoting angiogenesis and having low immunogenicity, its clinical use is limited by challenges such as trimming to fit small holes and complications during insertion. To overcome these issues, decellularized amniotic membrane (dAM) has been processed into a hydrogel form, enhancing its applicability and allowing it to be used as an injectable hydrogel for minimally invasive therapies. While dAM hydrogels have been used in various medical fields, their application in intraocular surgery is new. This study proposes using dAM hydrogel for large macular hole closure, comparing its effectiveness to the inverted ILM flap technique in a randomized controlled trial.

NCT ID: NCT06359548 Recruiting - Macular Holes Clinical Trials

PEELED INTERNAL LIMITING MEMBRANE REPOSITION

Start date: April 15, 2024
Phase: N/A
Study type: Interventional

Macular hiatus (MH) refers to a tissue defect in the photoreceptor cell layer of the inner boundary membrane of the optic disc in the macular region. Among them, idiopathic macular hiatus (IMH) is more common in people over 60 years old and is a common eye disease. With the aging of society, the number of patients increases, and it severely damages the patients' vision and life quality. Previously, the conventional surgical approach for treating MH was vitrectomy combined with inner limiting membrane (ILM) peeling. Although the closure rate of MH is high, many damages to the morphology and function of the ILM peeled area have been found. Our team firstly report a novel technique of peeled ILM reposition. Compared to traditional ILM peeling, the novel technique peeled ILM reposition maintains the integrity of internal retina by "pull" back the ILM flap. The previous pilot clinical study suggests that the novel technique peeled ILM reposition surgical intervention can achieve better morphology and functional prognosis. However, there is currently a lack of larger sample size prospective randomized controlled studies to further clarify the clinical efficacy of this new surgical technique in treating IMH. This study aims to conduct a single center, prospective, and randomized controlled study, combined with previous work, to analyze the efficacy of this novel technique peeled ILM peeling in the treatment of IMH. We hypothesize that this novel technique can achieved better morphological and functional prognosis compared to traditional ILM peeling.

NCT ID: NCT06323902 Completed - Macular Holes Clinical Trials

Autologous Platelet-rich Plasma as a Treatment for Macular Holes

Start date: October 25, 2022
Phase:
Study type: Observational

For a series of patients with full-thickness macular hole, an autologous plasma rich in growth factors was developed in the form of a clot and applied to the retinal defect. These patients were followed up for a period of one year, obtaining substantial improvement both anatomically and functionally.

NCT ID: NCT06233500 Recruiting - Macular Holes Clinical Trials

Macular Micro Vascular Changes Following Macular Hole Repair : Optical Coherence Tomography Angiography Study

Start date: December 1, 2021
Phase: N/A
Study type: Interventional

The goal of this prospective interventional study is to to compare the micro vascular and structural changes between surgery with and without ILM flap to repair macular hole. The main questions it aims to answer are: - What are the macular micro vascular and structural changes pre and post repair of idiopathic full thickness macular hole and what is the correlation between these changes and visual recovery. - Is there are any prognostic values of the micro vascular status of the macula could be assessed preoperatively. - What are the differences regarding these micro vascular and structural changes between repair with and without ILM flap. Participants will be: - Subjected to pars plana vitrectomy to repair macular hole. - Examined by optical coherence tomography angiography pre and post operative Researchers will compare: Group A: eyes treated without ILM flap Group B : eyes treated by ILM flap to see if there are differences regarding the micro vascular and structural changes in the macular area.

NCT ID: NCT06211907 Not yet recruiting - Macular Holes Clinical Trials

Small Macular Holes Treated With Air

Start date: February 1, 2024
Phase: N/A
Study type: Interventional

Non-inferiority trial comparing intraocular air and gas tamponade for closure of macular holes.

NCT ID: NCT06200727 Active, not recruiting - Glaucoma Clinical Trials

Platelet-rich Fibrin(PRF) Membrane in Ophthalmic Diseases

Start date: January 1, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to observe the role of PRF in treating ophthalmic diseases.The efficacy and safety of PRF were validated for four ophthalmic conditions: macular hole, pterygium, corneal ulcer, and patients undergoing trabeculectomy for glaucoma. The main question aims to answer is PRF's effectiveness in ocular surface and fundus diseases. Participants will be divided into 2 groups, the experimental group will be treated with PRF and the control group will be treated with conventional surgery, with a 12-month postoperative follow-up to determine the role of PRF on wound healing in ophthalmic diseases.

NCT ID: NCT06115005 Recruiting - Macular Holes Clinical Trials

Treatment of Challenging Macular Holes Using Plasma Rich in Growth Factors

Start date: June 1, 2022
Phase: Phase 2
Study type: Interventional

Aim of the Study:To report the structural and visual outcomes of plasma rich in growth factors in closure of challenging macular holes

NCT ID: NCT06079593 Not yet recruiting - Macular Holes Clinical Trials

GaslEss Macular Hole Surgery

GEM
Start date: January 1, 2024
Phase: N/A
Study type: Interventional

Macular holes are a hole in the centre of the retina, the light-sensing layer in the back of the eye. They cause a central 'blind spot' in the vision, which can be very disabling for patients. Standard surgery involves injecting a large gas bubble inside the eye. This takes 4-8 weeks to leave the eye. During this time vision is greatly reduced in the eye. This limits patients' ability to drive and work. Gas causes clouding of the natural lens in the eye (cataract). The gas can also raise pressure inside the eye, causing pain and sometimes loss of vision. Patients cannot fly or have certain medicines until the gas absorbs. Critically, most patients position face down for 50 minutes out of every hour for a week after surgery. This is to float the gas bubble onto the macula. Head positioning is particularly difficult. It very often causes pain in the neck, back, arms and legs. Rarely, blood clots can form in the legs and be life-threatening if they dislodge and travel to the lungs. Head positioning also places a large burden on those caring for the patient. The gases are 'greenhouse' gases and cause damage to the environment, for about 3,200 years. This study looks at a new surgical technique for treating macular holes. The new technique aims to make patients' recovery from surgery easier, and safer. The purpose of this study therefore is to compare two treatments: - Standard macular hole surgery with gas tamponade - Novel macular hole surgery without tamponade Gathering feasibility data to inform a future fully powered trial

NCT ID: NCT06063005 Recruiting - Macular Holes Clinical Trials

Clinical Study of Translocated Internal Limiting Membrane Flap Reposition for the Treatment of Idiopathic Macular Hole

Start date: July 1, 2022
Phase: N/A
Study type: Interventional

The main objective of this study is to evaluate the therapeutic effectiveness of the internal limiting membrane (ILM) peeling and translocation surgery compared to the conventional surgical approach for treating large idiopathic macular hole (IMH) through a well-designed prospective randomized controlled clinical trial. This study aims to compare the new surgical approach to the conventional approach in terms of improving visual function, promoting macular retinal anatomical healing, and enhancing patients' quality of life. By conducting this prospective clinical trial, establishing a database, and generating clinical reports and evidence-based medicine on the therapeutic efficacy of the ILM peeling and translocation surgery for large IMH.

NCT ID: NCT06000111 Recruiting - Macular Holes Clinical Trials

Duration of Face Down Positioning for Full-Thickness Macular Hole Repair

Start date: November 21, 2023
Phase: N/A
Study type: Interventional

A full-thickness macular hole is when there is a small gap that opens in the center part of the retina (the light-sensitive layer of tissue in the back of the eye). Following surgical repair of these holes, patients have to lie face down for a number of days and nights. The exact amount of time necessary to position is however unknown. The goal of this randomized feasibility clinical trial is to compare 3 days and nights of face-down positioning to 7 days and nights of face-down positioning following pars plana vitrectomy surgery for full-thickness macular holes on key patient outcomes. This study will be a feasibility study to better inform a future larger clinical trial. Additionally, this investigation will be examining the rates of macular hole closure, patient visual acuity following surgery, patient quality of life, patient compliance, and complication rates.