20 Clinical Trials for Various Conditions
This study seeks to evaluate the effect of the intravitreal 0.7mg dexamethasone implant on central macular thickness and visual acuity in those patients with persistent macular edema after pars plana vitrectomy for epiretinal membrane.
Prospective, observational cohort study evaluating the association between pre-surgical existence of an epiretinal membrane (ERM) and the development of pseudophakic cystoid macular edema (PCME) using spectral domain optical coherence tomography (OCT) measurements.
The purpose of this study is to evaluate the effect of dexamethasone intravitreal implant (Ozurdex) in combination with pars plana vitrectomy and membrane peeling for idiopathic epiretinal membrane (ERM).
The purpose of this study is to compare the macular volume of patients treated with a 3-month course of topical Nepafenac (0.1% solution) to patients treated with a placebo course following epiretinal membrane surgery.
An epiretinal membrane is scar tissue on the retina that can cause blurring and distortion of vision and lead to swelling, or macular edema. Despite surgery to remove the scar tissue(membrane peeling), residual swelling of the retina may continue to interfere with vision. In this study the investigators will inject an implantable steroid device into the back, fluid-filled portion of the eye. Steroids have been found to decrease the swelling in the retina. Ozurdex™ is an implantable steroid. Once implanted, Ozurdex™ is slowly dissolved by the vitreous gel that fills the eye, releasing the steroid. The steroid drug delivery system in this study, known as Ozurdex™ has been FDA-approved by the US Food and Drug Administration (FDA) for decreasing swelling due to another condition in the eye. This study will help to find out whether or not this device Ozurdex™ is also effective for reducing the swelling of the retina in patients who have already had surgery to remove scar tissue on the retina.
Vitrectomy to remove an epiretinal membrane (ERM) is one of the most common procedures performed by retinal surgeons. Patients who present with significant macular changes on optical coherence tomography (OCT) but relatively good vision are often advised to defer surgery until vision declines to 20/40 or worse. However, it is unknown if delaying surgery, which allows the foveal architecture to remain compromised and potentially to deteriorate, results in worse visual acuity outcomes than if surgery is performed earlier. In addition, there is a need to better understand predictors of outcomes when surgery is performed and predictors of progression when surgery is deferred. Finally, one of the most common presenting symptoms from an ERM is distortion or metamorphopsia. There are several objective measures of metamorphopsia but none have ever been employed to evaluate ERMs in a randomized clinical trial (RCT) and their usefulness is unknown. The purposes of this study are to better understand the optimal timing of surgery to produce the best visual result, to better understand predictors of outcomes in those who undergo surgery and predictors of progression in those whose are observed, and to better characterize and evaluate the usefulness of metamorphopsia and reading speed measures.
To prospectively compare clinical outcomes using straight (perpendicular) versus angled trocar insertion during 27 gauge pars plana vitrectomy surgery for epiretinal membrane Primary Endpoints: Sclerotomy suture rates and incidence of suture blebs at the end of 27 gauge MIVS. Secondary Endpoints: Rate of postoperative wound-related complications such as hypotony, choroidal detachments, endophthalmitis, and sclerotomy-related retinal tears with a minimum follow-up of 30 days.
Epiretinal membranes (ERM) are cellular membranes on the surface of the retina that result in distortion of the vision (metamorphopsia), and decreased best-corrected visual acuity. They are most frequently found in patients over the age of 50 and have a reported prevalence of 7-12%. \[1,2\] Epiretinal membranes are caused by posterior vitreous separation, retinal detachment, proliferative vitreoretinopathy, cataract surgery, trauma, inflammation, retinal vascular disease, and idiopathic. \[1-4\] Epiretinal membrane removal by pars plana vitrectomy combined with internal limiting membrane peeling leads to improved vision, decreased metamorphopsia, and improved quality of life after surgery. \[2\] Internal limiting membrane (ILM) peel has been associated with decreased rates of epiretinal membrane recurrence and is also performed during vitrectomy for repair of macular holes or vitreomacular traction. \[5,6\] Internal limiting membrane peeling can be performed by using an instrument to make a break in the membrane followed by peeling with forceps, or by utilizing ILM forceps alone to pinch and peel an unviolated ILM. No study exists comparing different intraoperative techniques used for ILM peeling on visual outcomes and operating time. The investigators hypothesize that using a "pinch and peel" technique will equal outcomes with shorter operating time than other techniques. 1. McDonald HR, Johnson RN, Ai E, Jumper JM, Fu AD. Macular epiretinal membranes. Retina, 4th edition, editor Ryan SJ, Wilkinson CP, 2006, p 2509-2525. 2. Ghazi-Nouri SM, Tranos PG, Rubin GS, Adams ZC, Charteris DG. Vitrectomy and epiretinal membrane peel surgery visual function and quality of life following. 2006;90;559-562; Br. J. Ophthalmol 3. Haritoglu C, Gandorfer A, Gass CA, Schaumberger M, Ulbig MW, Kampik A. The Effect of Indocyanine-Green on Functional Outcome of Macular Pucker Surgery. AM. J. Ophthal. VOL. 135,NO.3, 328-337, Mar 2003 4. Hiscott PS, Grierson I, McLeod D. Retinal pigment epithelial cells in epiretinal membranes: an immunohistochemical study. Br. J. Ophthalmol, 1984, 68, 708-715 5. Park DW, Dugel PU, Garda J, Sipperley JO, Thach A, Sneed SR, Blaisdell J. Macular Pucker Removal with and without Internal Limiting Membrane Peeling: Pilot Study. Ophthalmology Volume 110, 1, Jan 2003 6. Kwok AK, Lai TY, Yuen KS. Epiretinal membrane surgery with or without internal limiting membrane peeling. Clinical and Experimental Ophthalmology, 2005, 33:379-385
The purpose of this trial is to compare the ability of two doses of OT-551 ophthalmic solution and drug-free solution to safely and effectively prevent or delay the progression of nuclear cataracts that frequently develop as a result of vitrectomy (surgery for retina repair), thereby avoiding the need for a second surgery (cataract removal). Victrectomies involve removal of the jelly-like substance (vitreous) that is located in a cavity behind the lens.
The goal is to conduct a 5-year prospective, randomized controlled trial to test an innovative, community-based intervention using posterior and anterior fundus photography of the optic nerve and macula and intraocular eye pressure measurements to improve access and utilization of eye care to detect, treat, and manage high-risk patients with previously undiagnosed glaucoma and other eye diseases. Research shows that subject failure to attend follow-up eye care appointments diminishes any previous benefits of community screenings for glaucoma. Greater adherence to follow-up visits can reduce glaucomatous blindness.
This phase I trial will assess primarily the safety and secondarily the anti-inflammatory and anti-neovascular effect of Episcleral Celecoxib in patients suffering from macular edema and other inflammatory disorders of the retina, choroid and vitreous.
This phase I trial will assess primarily the safety and secondarily anti-inflammatory effect of Episcleral Dexamethasone in patients suffering from macular edema and other disorders of the retina, choroid and vitreous.
The overall five-year goals of the project are to develop novel technology to provide actionable new information through provision of live volumetric imaging during surgery, improving surgical practice and outcomes. The investigators believe this technology will enable novel ophthalmic and other microsurgeries not possible due to current limitations in surgical visualization.
Prospective study evaluating the role of inflammasomes in cell death in retinal detachment, full thickness macular hole, and epiretinal membrane. The investigators are collecting vitreous and subretinal fluid samples from patients with these conditions and evaluating activity of the inflammasome pathway with established assays.
Optical coherence tomography (OCT )provides high resolution information regarding the anatomic structure of the tissues of the eye in a cross-sectional and 3 dimensional view. Much of this information is not able to be visualized by a clinician. Utilizing this information during surgery will allow for the ophthalmic surgeons to better understand how surgical procedures impact the anatomic structure of the eye. In this study an OCT device that has been built into the microscope (rather than mounted on the side or held in the surgeon's hand) and will be utilized to take images at various milestones during surgery to assess feasibility and potential utility of this technology. Since it is built into the microscope, there are potential significant advantages over a separate system including increased efficiency, improved working distance, and the ability to visualize tissue-instrument interactions.
OCT provides high-resolution information regarding the anatomic structure of the tissues of the eye in a 2-dimensional and 3-dimensional view. Much of this information is not able to be recognized by a clinician. Utilizing this information during surgery will allow for ophthalmic surgeons to better understand how surgical procedures impact the anatomic structure of the eye.
To conduct a precision study to assess the microperimetry function of the Spectral OCT/SLO. The study will assess variability across measurements taken by three different operator-device configuration across clinical sites, variability between subjects within a given operator-device configuration, and variability within a subject for a single operator-device configuration.
The purpose of this study is to compare the newly released Spectral OCT/SLO (OTI, Toronto, Canada) with the Zeiss Stratus OCT (Carl-Zeiss Meditec, Dublin, CA) with regards to the quality of the images obtained as well as the ease of use.
This study will examine the use of the dexamethasone implant (Ozurdex) in patients with macular edema associated with an epiretinal or preretinal membrane requiring surgical intervention. After the surgery is performed (pars plana vitrectomy), an Ozurdex implant will be placed in the eye. Patients will be followed for 1 year.
Vitreomacular adhesion causes symptoms of blurry vision, distortion, and double vision. It is due to an abnormal separation of the vitreous gel from the surface of the retina and macula. The current, gold-standard treatment for this condition involves surgery performed in the operating room that involves risk such as bleeding, infection, cataract, and retinal detachment. It has been previously shown that a less invasive intravitreal injection of a gas bubble performed in the office may also treat vitreomacular adhesion with less risk than surgery. The purpose of this study is to determine the effect of an office-based injection of an intravitreal gas bubble as a treatment for symptomatic vitreomacular adhesion.