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NCT06347302
Retinal detachment is a condition with an estimated incidence of between 9.5 and 18.2 cases per 100,000 individuals. It is an ophthalmological emergency that threatens visual acuity and requires surgery. However, despite satisfactory post-operative anatomical results, vitreoretinal proliferation and photoreceptor death can still have a negative impact on visual prognosis. These complications are still not fully understood. A previous study carried out by the Eye, Nutrition and Cell Signalling team at the CSGA, comparing mouse models of retinal detachment with healthy control retinas, revealed an increase in pro-inflammatory cytokines and a change in retinal lipid abundance in detached retinas. However, these results have yet to be confirmed in humans. Our main hypothesis is that the vitreous content of omega-3 PUFAs and proteins is altered during the onset of retinal detachment, since it reflects both intraocular inflammation and photoreceptor apoptosis. We therefore wish to demonstrate that the protein and PUFA contents of the vitreous humour are different between eyes with retinal detachment and eyes not affected by retinal detachment after macular surgery (epiretinal membrane or macular hole). We would like to show that the vitreous PUFA content is lower in the macular surgery group due to the absence of photoreceptor apoptosis and the absence of dehiscence causing communication between the subretinal space (photoreceptors whose membranes are very rich in PUFAs) and the vitreous space. We also hope to identify changes in the protein composition of vitreous fluid in patients with retinal detachment, with overexpression of proteins involved in inflammation pathways. In addition, we hypothesise that retinal omega-3 PUFA content is a factor influencing retino-vitreal proliferation and functional and anatomical recovery from retinal detachment. To this end, we will study the correlation between retinal PUFA-3 content and the clinical presentation and postoperative course of retinal detachment. Finally, with the aim of identifying a serum marker for the prognostic evaluation of retinal detachment, we will use as a candidate a biomarker of retinal omega-3 PUFA content that we have developed in an Age-Related Macular Degeneration (AMD) model. We will analyse the correlation between this biomarker and levels of omega-3 PUFAs measured directly in the retina. To do this, we will analyse intraoperative samples of vitreous humour, sub-retinal fluid and retinal fluid from patients undergoing vitrectomy for retinal detachment in the Ophthalmology Department of the Dijon University Hospital. A group of control patients will consist of patients operated on by vitrectomy for macular surgery (epiretinal membrane or macular hole) for whom a vitreous humour sample will also be taken. Clinical information on the characteristics of the retinal detachment will be collected. During the consultation, the patient will be questioned about any history of dyslipidaemia and any current treatment, including the use of lipid-enriched food supplements. Post-operative follow-up with prospective collection of clinical and paraclinical data on anatomical and functional evolution will be carried out up to 6 months after the occurrence of retinal detachment. A blood sample will be taken to establish a lipid profile in all patients. We will thus gain a better understanding of the changes in lipid and protein content in the vitreous humour, sub-retinal fluid and retina, and the demonstration of a link between the initial presentation and the postoperative anatomical and functional evolution of retinal detachment. This will provide a better understanding of the lipid-dependent mechanisms linked to inflammation and photoreceptor degeneration during retinal detachment, and will ultimately make it possible to develop new therapeutic strategies to improve visual prognosis.
NCT07054281
This purpose of this study is to compare the safety and effectiveness of two eye surgery systems-UNITY VCS and CONSTELLATION-in treating adults with vitreoretinal diseases or disorders.
NCT05331664
To demonstrate that intraoperative use of subtenon triamcinolone acetonide at the time of surgery without postoperative eye drops is non-inferior to the regimen of postoperative eye drops following primary pars plana vitrectomy for retinal detachment.
NCT06997874
Background and study aims The retina is the layer at the back of the eye that allows us to see. Sometimes, it can detach from the wall of the eye, causing a condition called rhegmatogenous retinal detachment (RRD), which leads to vision loss and requires surgery. The most common surgery for RRD is vitrectomy, but this can lead to complications like cataracts, which worsen over time and need to be removed with another surgery. Cataract surgery involves replacing the cloudy lens with a clear artificial one. Currently, it's unclear whether it's better to perform both surgeries at the same time or separately. The COMBAT study aims to find out which approach is best by comparing the outcomes of patients who have vitrectomy alone versus those who have both surgeries (vitrectomy and cataract surgery by phacoemulsification and intraocular lens \[IOL\] implantation) together. Who can participate? Adults aged 50 and older who have RRD but are not highly myopic (less than -6 diopters or an axial length of 26.5 mm or less) and have not had previous vitreoretinal surgery. Participants must be scheduled for a pars plana vitrectomy to repair their RRD. What does the study involve? Participants will be randomly assigned to one of two groups: one group will have vitrectomy first and, if needed, cataract surgery later; the other group will have both surgeries at the same time. The study will compare their vision, the number of successful retina reattachments, health related and visual related quality of life, patient satisfaction, complications, additional surgeries and procedures, and costs.
NCT06694259
Rhegmatogenous Retinal Detachment is a pathological condition in which the inner layers of the retina separate from its outermost layer due to fluid entering between these layers through a retinal tear. Retinal detachment is one of the most urgent conditions in ophthalmology; if left untreated, it leads to severe vision loss and blindness. The only possible treatment is a surgical procedure to close the tear and reattach the separated retinal layers. Currently, three techniques are used for surgically managing retinal detachment with a tear. You will undergo a technique called pneumatic retinopexy. In this procedure, reattachment of the retina is achieved by injecting sulfur hexafluoride gas (SF6) into the vitreous (the gel that fills the eye) about 4 millimeters from the corneal edge, using a very fine needle. The retinal tear is then closed by either freezing (cryotherapy) immediately before the gas injection or by laser photocoagulation after the gas is introduced. The procedure will be done under local anesthesia, with the pupil first dilated using eye drops. After the procedure, a combination of antibiotics and corticosteroids will be instilled in the eye, followed by an ointment of the same combination, and the eye will be covered with a sterile dressing. You will need to maintain a specific head position, depending on the location of the retinal tear, for several days while the gas is present in the eye. This position helps the gas press against the tear, allowing it to heal. During this time, you should keep your head elevated, even at night, almost in a sitting position. Since the gas is lighter than the vitreous and rises within the eye, your head position should keep the tear positioned at 12 o'clock so the gas bubble can mechanically close it. Proper patient selection is essential for this procedure: only patients with retinal tears limited to the upper half of the retina, with one or more tears within an hour area of the peripheral retina, are suitable for this technique. The gas does not need to be removed, as it will spontaneously reabsorb over 6-7 days. While it is in your eye, you will see it as a single bubble that will gradually shrink over 6-7 days before disappearing. If you experience severe pain on the first day, notify your surgeon, as gas expansion within the eye could cause a temporary rise in eye pressure in the first 24-48 hours. You will need to remain in the same head position at home while the gas is present in your eye. While the gas is in place, you must not fly, as cabin pressure changes could cause the gas to expand. If you are unable to maintain the necessary position, this procedure may not be suitable for you, and an alternative technique would be needed. This technique is less invasive than the two other surgical treatments for retinal detachment. It is performed under local anesthesia, is brief, carries fewer risks, and does not require additional follow-up procedures if the surgery is successful, which largely depends on your adherence to postoperative care.
NCT06610786
The objective of the study is to evaluate: 1. Safety and efficacy of a novel foldable capsular scleral buckle (FCSB) in scleral buckling for primary rhegmatogenous retinal detachment (RRD) of medium complexity. 2. Comparison between FCSB and pars plana vitrectomy in therapeutic effects and complications in the treatment of primary RRD of medium complexity.
NCT06541574
I. Title Prevention of ProliFerative Vitreoretinopathy with Intravitreal MethotreXate in Primary Retinal DEtachment Repair (FIXER) Trial * Today's Date: September 18, 2023 II. Principal Investigator * Principal Investigator: Christopher D. Riemann, M.D. (Cincinnati Eye Institute) * Email: criemann@cvphealth.com, Phone: 513-708-1979 V. Research Summary Purpose: To evaluate methotrexate for the prevention of PVR after primary rhegmatogenous retinal detachment repair. Methods: Inclusion Criteria: • Any adult patient, age ≥18 years-old, undergoing primary rhegmatogenous retinal detachment surgery with pars plana vitrectomy at the Cincinnati Eye Institute in Blue Ash, Ohio who is able to give informed consent. Exclusion Criteria: * Age \<18 years old * Pregnant patients or patients of child bearing potential unwilling to utilize long term contraception for the 12-week period spanning vitrectomy surgery for retinal detachment repair up until the 3 month postoperative visit. * History of endophthalmitis, ruptured globe or significant trauma in the affected eye * Chronic retinal detachment (symptoms greater than or equal to six weeks) * Any previous previous retinal detachment repair with pars plana vitrectomy, or scleral buckling surgery. Patients having undergone previous pneumatic retinopexy will not be excluded. * Presence of Grade C PVR: full thickness retinal folds or subretinal bands * Patients with contraindications to methotrexate, including breastfeeding, pregnancy, attempting to conceive a child or any known hypersensitivity or intolerance to methotrexate * Patients with diminished mental capacity precluding their ability to give informed consent. Study Design and Randomization This prospective double masked trial will randomize patients into four groups in a 1:1:1:1 fashion. All attending surgeons and patients will be masked to group randomization. Randomization into four groups will occur on the day of surgery by the Cincinnati Eye Institute's pharmacist, Deepali Chachare. Group A will consist of ≥ 150 patients receiving intraoperative infusion with balanced salt solution containing methotrexate (40mg/500mL BSS), and methotrexate intravitreal injections (400mcg/0.05mL) at postoperative weeks 1, 3, 6, and 10. Group B will consist of ≥ 150 patients receiving intraoperative balanced salt solution infusion containing methotrexate, and sham intravitreal injections at postoperative weeks 1, 3, 6, and 10. Group C will consist of ≥ 150 patients receiving a balanced salt solution infusion without methotrexate, and methotrexate injections at postoperative weeks 1, 3, 6, and 10. Group D will consist of ≥ 150 patients receiving intraoperative balanced salt solution infusion without methotrexate, and sham intravitreal injections at postoperative weeks 1, 3, 6, and 10.
NCT05588037
Based on the progress of cataract surgery, intraocular lens development, vitreoretinal surgery and anesthesia technology in recent years, the purpose of this study is to develop a new type of more accurate and minimally invasive combined surgery for cataract and fundus diseases, and to evaluate the advantages and value of the surgery as well as related complications, so as to minimize the surgical trauma and obtain faster visual function recovery and better patient comfort. To provide new solutions for the growing demand of eye health care.
NCT02834559
This study investigates the effectiveness of a simple treatment to prevent proliferative vitreoretinopathy (PVR). Intraoperative intravitreal 5-fluorouracil (5-FU) and low molecular weight heparin (LMWH) is used as a prophylactic therapy in high-risk patients with primary rhegmatogenous retinal detachment (RRD). Our major motivation is to reduce the incidence of PVR in the group that receives the trial drug.
NCT04571788
To evaluate the efficacy and safety of treating rhegmatogenous retinal detachment (RRD) using foldable capsular buckle (FCB). It is a multi-center clinical ,randomized, controlled, and single-blind clinical study.
NCT04520789
Study of initiating proliferative vitreoretinopathy (PVR)cell subtype (PVR initiating cells (PVR-IC) in RPE cells of rhegmatogenous retinal detachment (RRD) patients; to prove the percentage of PVR-IC decides the risk of serious PVR occurring after surgery; to investigate the safety and efficacy of early local steroids drug intervention in patients with severe postoperative PVR.
NCT00370201
This clinical trial will test the efficacy and safety of oral colchicine in prevention of proliferative vitreoretinopathy (PVR) in cases of rhegmatogenous retinal detachment