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Retinal Perforations clinical trials

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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: 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: 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: 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.

NCT ID: NCT05860985 Recruiting - Retinal Detachment Clinical Trials

Zeiss RESIGHT Disposable Lenses Evaluation Study

RESIGHT
Start date: April 11, 2023
Phase: N/A
Study type: Interventional

To evaluate the intra-operative efficacy of a new intra-operative viewing device.

NCT ID: NCT05828251 Recruiting - Clinical trials for Full Thickness Macular Hole

Full Thickness Macular Hole; Should it be Handled Subacutely?

Start date: April 30, 2023
Phase: N/A
Study type: Interventional

Full thickness macular hole, FTMH, is a retinal disease involving the fovea that cause central vision loss, metamorphopsia and central scotoma. The most effective treatment for FTMH is a pars plana vitrectomy and a tamponade with expansile gas. It is well known that vitrectomy accelerates cataract development. Vitrectomy can therefore be combined with cataract surgery in the same setting, a procedure that is shown to be safe, although increased inflammation and rates of central macular edema have been reported in some studies. Cataract surgery can also be performed prior or deferred until compromising the visual acuity after vitrectomy. Cataract-surgeries are more challenging in vitrectomized eyes due to lack of vitreous support and risk of loose zonules. The normal practice for FTMH at our department is therefore cataract surgery followed by vitrectomy 4 weeks later. A combined phaco-vitrectomy procedure is offered to patients who are at the labor market or when general anesthesia is required for the surgery. In non-presbyopic patients (<50 years) only vitrectomy is performed. The visual improvement after surgery seems to be dependent on preoperative characteristics, such as the preoperative visual acuity, size of the hole and the duration of symptoms. The duration of symptoms is a known prognostic factor, and recently shown that the longer duration, the worse visual outcome. The precise timeframe for the optimal final outcome is not known. The combined surgery is known to be safe in the treatment for epiretinal membrane, where a intravitreal gasfill is not necessary. However, the use of gas in FTHM surgery causes risk of increased movement of the newly inserted intraocular lens. This can lead to increased anterior segment inflammation with ensuing vision threatening cystic macular edema, as mentioned above. The purpose of this study is to investigate whether small FTMH with a short duration of symptoms have better visual outcome with a prompt combined phako-vitrectomy (within two weeks), compared to the current standard of care of receiving cataract surgery as soon as possible and vitrectomy 4 weeks later. How the delay of surgery affects the visual outcome will also be investigated, by including patients with longer duration of symptoms. The main hypothesis is that the chance of better visual outcome is higher for macular holes with early surgery compared to the current standard of care and that the duration of symptoms has significant impact on the visual outcome. Method The study consists of 2 parts. 1. Patients with idiopathic FTMH <400µm in diameter (as defined by The international vitreomacular traction study group classification), with a duration of symptoms of less than 30 days will be randomized into 2 groups: Group1: Combined phaco-vitrectomy within 2 weeks (after referral). Group 2: Current standard of care with cataract surgery as soon as possible and vitrectomy 4 weeks later. 2. Group 3: Patients with small holes <400µm, with a duration of symptoms of more than 3 months and less than one year will be included in this part of the study. These patients will be treated and followed as in Group 2. They will be reviewed a total of 7 times in Group 1 and 9 times in Group 2 and 3: a preoperative examination followed by 6/8 postoperative examinations. Additional examinations will be scheduled if needed.

NCT ID: NCT05757349 Recruiting - Clinical trials for Idiopathic Macular Hole

Analysis of Novel Positioning Sensor-assisted Postoperative Position Correction and Effective Prone Time Recorded in Patients With Different Prone Times After Macular Hole Surgery

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

Idiopathic macular hole (IMH) is a fundus disease without clear etiology, most often seen in healthy women over 50 years of age, and is often associated with ocular manifestations such as loss of central vision and visual distortion. It is often associated with loss of central vision, visual distortion, and other ocular manifestations. It is currently treated by vitrectomy combined with internal limiting membranes (ILM) peeling followed by gas filling. A strict prone position for a certain period of time after surgery has a positive effect on the healing of the macular fissure. The need for a strict prone position after IMH has been demonstrated in previous studies (especially when the IMH diameter is >400 μm). However, due to the anti-human mechanics of the face-down position, patient comfort, sleep quality and quality of life are greatly compromised. Therefore, this study designed a smart head position monitoring device to assist patients in maintaining the correct position and recording the effective position time. The study was conducted to determine the shortest prone position time based on macular fissure closure, to minimize the adverse effects of postoperative position, and to obtain the maximum recovery of visual acuity and visual field.

NCT ID: NCT05747144 Recruiting - Retinal Detachment Clinical Trials

Multimodal Imaging in Vitreo-retinal Surgery and Macular Dystrophies

MICAI
Start date: January 15, 2021
Phase:
Study type: Observational

The aim of the study is to identify morphological and functional biomarkers of post-operative recovery after vitreoretinal surgery, using decisional support systems (DSS), based on multimodal big-data analysis by means of machine learning techniques in daily clinical practice

NCT ID: NCT05396209 Recruiting - Macular Holes Clinical Trials

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

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

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).