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Retinal Perforations 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: 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: 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: NCT04459949 Not yet recruiting - Epiretinal Membrane Clinical Trials

Comparative Study of Sharkskin Versus Grieshaber Forceps During ILM Peeling

Start date: July 6, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the performance and anatomic outcomes of the Sharkskin internal limiting membrane (ILM) forceps and the Grieshaber ILM forceps in macular surgery. Peeling of the ILM is a difficult aspect of vitreoretinal surgery and often daunting task from a vitreoretinal fellow's perspective. The hypothesis is that the newer Sharkskin forceps have a larger platform and micro-abrasions along the forcep surface to increase grasping ability and potentially limit trauma to the retina surface compared to the Grieshaber forceps. This project may also serve as an education tool for fellows learning the basics of ILM peeling.

NCT ID: NCT04346095 Not yet recruiting - Retinal Detachment Clinical Trials

Oral Sedation in Vitreoretinal Surgery

Start date: June 2020
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare the efficacy of oral sedation to intravenous sedation with anesthesiology support and monitoring.

NCT ID: NCT04212624 Not yet recruiting - Clinical trials for Degenerative Myopia With Macular Hole

Clinical Research of Human Retinal Pigment Epithelial (HuRPE) Cell Injection on Atrophy of High Myopia Macular Area

Start date: December 2019
Phase: N/A
Study type: Interventional

To evaluate the safety and tolerability of human retinal pigment epithelial (HuRPE) cell injection subretinal transplantation for atrophy of high myopia macular area, and to explore the maximum tolerated dose (MTD).

NCT ID: NCT03805763 Not yet recruiting - Macular Holes Clinical Trials

Clinical Research on the Effect of Different Extents of Internal Limiting Membrane Peeling on Macular Hole Closure and Visual Acuity

Start date: February 1, 2019
Phase: N/A
Study type: Interventional

Observing and describing the surgical effects of different extents of internal limiting membrane peeling combined with internal limiting membrane insertion for macular hole

NCT ID: NCT03287102 Not yet recruiting - Macula Hole Clinical Trials

Macular Hole Surgery With Temporal Inverted Internal Limiting Membrane Flap (MARTIAL)

MARTIAL
Start date: February 1, 2018
Phase: N/A
Study type: Interventional

Since 1991, idiopathic macular holes (MH) can benefit from an effective treatment initially involving pars plana vitrectomy, stripping of epiretinal membranes and intraocular gas tamponade followed by facedown positioning. The initial 58% success rate has further increased to 85-100% with internal limiting membrane (ILM) peeling. However, complete ILM removal has been shown to lead to anatomic changes causing the retina to have the appearance of a dissociated optic nerve fiber layer (DONFL). Moreover, it has been associated with decreased retinal sensitivity that may cause visual discomfort despite good visual acuity. Nawrocki et al. recently suggested to reduce the area of peeled ILM (temporal inverted ILM flap technique) in order to minimize iatrogenic trauma while maintaining satisfactory surgical outcomes. The aim of this study is to compare the incidence of DONFL appearance and retinal sensitivity after macular hole surgery in eyes that underwent temporal inverted ILM flap technique and eyes that had complete ILM peeling