Clinical Research Directory

Community-Based Eye Screening With Structured Referral Tracking for Preventing Avoidable Blindness in Adults in Rawalpindi, Pakistan

This cluster randomized controlled trial aims to evaluate the effectiveness of a Structured Referral Tracking (SRT) intervention in improving referral completion among adults identified with avoidable blindness during community-based eye screening camps in Rawalpindi District, Pakistan. Ten community clusters will be randomized into intervention and control groups. Participants in the intervention group will receive structured referral counseling, weekly reminder calls or messages, and customized referral guidance for eight weeks, while the control group will receive standard referral procedures. The primary outcome is referral completion at a tertiary eye hospital within eight weeks after screening. Secondary outcomes include knowledge regarding avoidable blindness, treatment satisfaction, feasibility, acceptability, and barriers influencing referral completion.

Rocklatan vs Latanoprost Post-DSLT

This is a randomized, double-masked, single-site, prospective, contralateral eye study designed to evaluate the outcomes of Direct Selective Laser Trabeculoplasty (DSLT) followed by the addition of combination netarsudil and latanoprost (Rocklatan) versus latanoprost monotherapy. The study will be conducted at one investigational site. The primary endpoint is the change in mean diurnal intraocular pressure (IOP) from baseline (post DSLT and post washout) at visit 3 between the two groups. Secondary endpoints include the change in mean IOP from baseline at each timepoint (8am, 12pm, 4pm) at visit 3 between groups, and the mean percentage decrease in IOP from baseline for each group. Assessments will be conducted at three key visits: Visit 1 (Screening Phase and DSLT Procedure on Day 0), Visit 2 (Baseline Visit post washout at Week 8), and Visit 3 (Follow-Up Visit 1 at Week 12). Each visit will include specific examinations and measurements such as visual field and OCT imaging, diurnal IOP measurements, and documentation of adverse events.

Intraocular Pressure During Static Apnea

This prospective observational study evaluated changes in intraocular pressure (IOP) during dry static apnea (STA) in breath-hold divers. Forty participants performed voluntary breath-holds while intraocular pressure, peripheral oxygen saturation (SpO2), heart rate, and blood pressure were measured at baseline, during apnea, and after apnea. The aim was to assess the magnitude and dynamics of IOP changes and their relationship to physiological parameters.

Tear Interleukin Biomarkers After Glaucoma Treatment

This prospective study aims to evaluate inflammatory biomarkers in tear fluid in patients with glaucoma undergoing micropulse transscleral cyclophotocoagulation (MP-CPC), continuous-wave cyclophotocoagulation (CPC), and antiglaucoma surgeries. The study will assess the concentrations of pro- and anti-inflammatory interleukins in tear samples collected before treatment, 5-7 days after the procedure, and 1 month postoperatively. Intraocular pressure (IOP) will be measured at the same time points. The correlation between changes in interleukin levels and IOP reduction will be analyzed. Additionally, the study aims to compare inflammatory response patterns among the MP-CPC, CPC, and surgical treatment groups and to identify interleukin profiles associated with a clinically significant hypotensive effect.

Imaging the Effects of Netarsudil (Rhopressa) on the Trabecular Meshwork in Glaucoma and Ocular Hypertension

This study evaluates the effects of netarsudil (Rhopressa) on the trabecular meshwork in subjects with ocular hypertension or open-angle glaucoma. Participants will be randomized to receive either netarsudil or placebo (artificial tears). High-resolution imaging using adaptive optics gonioscopy, anterior segment optical coherence tomography (AS-OCT), and OCT gonioscopy will be performed at baseline and after approximately 14 days of treatment. The primary objective is to assess changes in trabecular meshwork lamellae spacing, with secondary measures including trabecular meshwork height, width, and Schlemm's canal diameter.

Progression of Disease in Patients Newly Diagnosed With Glaucoma and Glaucoma Suspects Participating in the GATE Study

The purpose of this study is to measure how many patients develop worsening glaucoma in the early years (2-4 years) of routine monitoring in hospital eye services. We will study a group of patients who were initially diagnosed as having glaucoma, or having high pressure in the eye (ocular hypertension) or having been diagnosed as a glaucoma suspect.

Phase 2 Study of BL1107 Eye Drops vs. Timolol in Adults With Primary Open Angle Glaucoma or Ocular Hypertension

Phase 2 Study of BL1107 Eye Drops vs. Timolol in Adults with Primary Open Angle Glaucoma or Ocular Hypertension

Comparison of Intraocular Pressure Measurement With the Novel TonoVera Device With Other Commonly Used Devices

We are testing the accuracy of Reichert's Tono-Vera tonometer by comparing measurements of IOP with this device and measurements with other commonly-used tonometers, including Goldmann Applanation and iCare.

Retinal Ganglion Cell Neuroprotection Under Prostaglandin Analogues

The goal of this observational study is to evaluate whether prostaglandin analogue eye drops have a direct neuroprotective effect on retinal ganglion cells - beyond their intraocular pressure (IOP)-lowering effect - in adult patients with glaucoma or ocular hypertension. The study includes individuals diagnosed with glaucoma (any sex/gender, adult age groups) undergoing standard clinical treatment. The main questions it aims to answer are: * Do prostaglandin analogues provide a neuroprotective effect on retinal ganglion cells that is independent of their IOP-lowering properties? * Should prostaglandin analogues be promoted/favoured over other IOP-lowering compounds for long-term glaucoma management? Researchers will compare an interventional group, which consist of 750 eyes treated with prostaglandin analogues (e.g., latanoprost, travoprost, tafluprost, bimatoprost, unoprostone), with a control group, which consist of 750 eyes treated with non-prostaglandin IOP-lowering compounds (e.g., timolol, dorzolamide, brimonidine, netarsudil) to see if treatment with prostaglandin analogues is associated with better retinal ganglion cell survival over a period of 3 years (36 months). Data will be collected from individuals who had at least 36 months of documented follow-up, with clinical data available at approximately 3, 6, 12, 24, and 36 months. Eligible individuals must have been treated with either prostaglandin analogues or other intraocular pressure (IOP)-lowering agents as part of routine clinical care. The data to be obtained from medical records will include at least: * Intraocular pressure readings * Visual field testing * OCT measures * Visual acuity * Adverse events * Treatment adherence/compliance * Additional glaucoma interventions

Reliability and Reproducibility of the Eye Check Tonometer

To investigate whether the new applanation tonometer (EyeCheck monitor) can provide intraocular pressure (IOP) measurements comparable to those of traditional tonometers such as the Goldmann applanation tonometer and the Tonopen.

The Role of Music in Enhancing Attention During Visual Field Exams for Pediatric Glaucoma Patients

The goal of the study is to see if the use of music improves attention during visual field exams for pediatric glaucoma patients.

Blinking Exercise Study

The goal of this clinical trial is to evaluate whether a structured blinking exercise can improve symptoms and signs of dry eye disease (DED) in adults with glaucoma who are using topical intraocular pressure-lowering medications. The study will also assess the effects of the intervention on tear film stability, blink function, and participant adherence to the exercise. The main questions this study aims to answer are: Does a two-week structured blinking exercise reduce dry eye symptoms, as measured by the Ocular Surface Disease Index (OSDI) and Symptom Assessment in Dry Eye (SANDE) questionnaires? Does the blinking exercise improve objective measures of ocular surface health, including non-invasive tear break-up time (NITBUT) and blink dynamics? Researchers will compare glaucoma patients receiving topical medications (intervention group) with glaucoma suspects not using topical therapy (control group) to evaluate the effectiveness of the blinking exercise on dry eye outcomes. Participants in both groups will receive instruction on a standardized blinking exercise protocol consisting of repeated close-squeeze-open blinking cycles performed three times daily for two weeks. Participants will attend study visits at baseline, 2 weeks (post-intervention), and 4 weeks (follow-up). At each visit, participants will complete validated dry eye questionnaires and undergo non-invasive assessments of tear film stability, blink characteristics, and meibomian gland function. Adherence to the blinking exercise will be monitored using self-reported logs or reminders.

Comparison of Visual Field Assessments Between Three Perimeters

A single center, prospective, randomized, comparative study of visual field assessments between the TEMPO, VisuALL, and HFA perimeters. Subjects will be assessed at 1 visit. Clinical evaluations will include MD, PSD, FT, VFI, OCT, and a questionnaire.

Intraocular Pressure Measured by a Novel Sensing Contact Lens Versus Tonometry

While elevated intraocular pressure (IOP) is no longer part of the definition of glaucoma it remains the sole proven modifiable risk factor for the onset and progression of glaucoma. IOP is known to vary with the time of day as well as with daily activities. The importance of the nycthemeral IOP pattern for successful management of glaucoma has been well documented, especially for patients who experience visual loss despite apparently normal and/or controlled IOP during office hours. The current way of assessing nycthemeral IOP fluctuation is to perform repeated discrete tonometry measurements, once per hour in the best cases. Since its development in the 50s, Goldmann applanation tonometry (GAT) has remained the gold standard method for measuring IOP, despite its limitations. However, tonometry may be an imperfect method for measuring changes in IOP because it allows only snapshot and non-continuous measurements, it is not physiologic and disturbs the sleep architecture. There have been many efforts in the past decades to search for an ambulatory and frequent method to monitor IOP for 24 hours. In this context, Sensimed AG has recently developed a sensing contact lens-based device intended to measure IOP over 24 hours, the Goldfish (GF). First-in-man data obtained with this device showed agreements between IOP measured by GF and values obtained by standard tonometry in the same eye, comparable to literature results for routinely used tonometry devices. However, this pilot study included 9 subjects only with improvable safety, tolerability and efficacy profiles. The main goal of this study is to assess IOP measurements with the GF and compare the values with those obtained by standard tonometry in patients with open angle glaucoma (OAG) and ocular hypertension (OHT).

Developing and Testing a Model to Identify Preventive Vision Loss Among Older Patients in General Practice

In this cohort study, the investigators will test vision screenings in Danish general practice for patients over 70 years of age with minimum one chronic condition. The main outcome is detection of vision impairment and secondary outcome is detection of conditions needing ophthalmologic follow-up but not presenting vision impairment at present time.

Strategies for Improving Linkage-to-Care After Eye Disease Screening

The goal of this randomized, parallel-group, controlled trial is to compare methods of improving linkage-to-care for participants in the Village Integrated Eye Worker II (VIEW II) trial who are referred to the eye hospital following eye disease screening. Participants who are referred to the hospital at an eye screening visit will be randomized to three different linkage-to-care interventions: (1) text message reminders, (2) reminders from health workers, or (3) no intervention. The primary outcome of the trial will be whether or not the participant presented to the eye hospital for a referral visit by 21 days following screening.

Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment

This pilot clinical trial evaluates whether non-invasive brain stimulation improves the orientation and mobility (O\&M) skills of individuals with constricted visual fields in both eyes. The study is composed of three visits. The first visit is meant to confirm eligibility by performing a few clinical tests. Eligible participants will then complete two additional visits, one in which the participants receive active stimulation, and one in which the participants receive placebo (sham) stimulation. Stimulation will be administered in a randomized, double-blind order. To evaluate improvement, various measures of O\&M performance will be assessed on a standardized obstacle course featuring static natural and artificial obstacles at defined intervals after the intervention. The investigators hypothesize that the application of brain stimulation to region of the brain responsible for visual processing will improve the orientation and mobility skills of individuals with binocular constricted visual fields immediately following stimulation, and the results will inform the design of a future, larger-scale study.

Glaucoma Drop Aids Part 2

Glaucoma medications are vital to disease management and prevention of further loss of vision as over time glaucoma will lead to irreversible blindness. The average size of a glaucoma medication bottle is around 10cc and these medications when used 2-3 times daily are expected to last patients an entire month. The investigators found that at Boston Medical Center (BMC) a majority of Yawkey Eye Clinic patients are unable to deliver the drops into their eyes due to poor vision or difficulty squeezing drop bottles. These patients also often deliver more than a necessary amount leading to premature completion of the bottle. However, because the cost benefit ratio of these drop aids is unclear, they are not routinely offered to the patients. Although the efficacy of these drop aids has not been well studied, if effective, the cost of these drop aids would more than pay themselves by improving medication compliance and visual function of the patients. This study aims to determine the efficacy of the Nanodropper in the BMC Yawkey Eye Clinic patient population.

The Role of Transscleral Cyclophotocoagulation in Patients Undergoing a Boston Keratoprosthesis

The Boston keratoprosthesis (KPro) is a special plastic device that is used to replace a sick cornea (transparent part of the eye, in front of the iris) in order to restore vision in patients who have failed traditional corneal transplants or have a very poor prognosis of success. Glaucoma is a chronic disease which causes optic nerve damage secondary to high pressure inside the eye and could lead to vision loss in the long term. Glaucoma is highly prevalent in patients who require a KPro and even more after their procedure. In order to decrease the intra-ocular pressure, surgeons can use multiple eyedrops. Unfortunately, following the KPro surgery, eyedrops lose their efficiency because they are less absorbed by the eye. The transscleral cyclophotocoagulation (TS-CPC) is a laser treatment used in advanced refractory glaucoma. This laser helps decrease the intra-ocular pressure and have a better control of the disease. There are different methods of laser transmission, including the continuous transmission (G-Probe) and the micro-pulsation method (Micopulse). Given the high prevalence of glaucoma in patients receiving a KPro, the investigators are studying the effect of giving the TS-CPC treatment prophylactically to patients before their Boston keratoprosthesis. Our hypothesis is that prophylactic TS-CPC will decrease glaucoma progression as well as the risks of developing glaucoma following the Boston keratoprosthesis . METHOD The investigators aim to recruit twenty (20) patients who are scheduled to receive Boston KPro. Participants will be randomized into two groups: 1) Groupe 1 will receive a prophylactic treatment of transscleral cyclophotocoagulation a G-Probe. 2) Groupe 2 will receive a prophylactic treatment of transscleral cyclophotocoagulation with a micropulse transmission (MicroPulse). The patients will receive their laser treatment by a glaucoma specialist 4 to 8 weeks before their KPro surgery. One week following their laser treatment, the participants will be examined by their glaucoma specialist. Following their KPro surgery, patients will have a follow-up at day-1, weeks 1 and 2, months 1 and 3, then every 4 to 6 months for 5 years. Additional non-invasive glaucoma tests will be performed twice during the first 3 months following the surgery and will be repeated every 4-6 months. Visual acuity results, the visual field tests and rates of post-operative complications will be compared between the different groups.

Electrical Stimulation for the Treatment of Glaucoma

The overall aim of this study is to see whether long-term electrical stimulation with a home-stimulation device works well and is safe for the treatment of open-angle glaucoma. Open-Angle Glaucoma is a disease where the nerves in the back of your eye die off faster than expected regardless of your eye pressure.

Change in IOP Fluctuation After DSLT

This is a prospective, single-center, single-arm, observational study designed to evaluate the change in diurnal intraocular pressure (IOP) fluctuation following Direct Selective Laser Trabeculoplasty (DSLT) in patients with primary open-angle glaucoma (POAG) who are on 1-3 IOP lowering medications. The study will be conducted at one site and will involve three key visits: a screening visit, a baseline/treatment visit, and a 6-month follow-up visit. During the screening visit, patients will undergo a comprehensive ophthalmic examination, and eligibility will be confirmed. The eye with the higher IOP will be selected if both eyes are eligible. At the baseline visit, diurnal IOP will be recorded at three time points (9am, 12pm, and 4pm) before DSLT is performed. The primary endpoint is the change in diurnal IOP fluctuation 6 months post-treatment. Secondary endpoints include changes in mean diurnal IOP and the proportion of eyes achieving a reduction in IOP fluctuations of ≥1 mmHg. Exploratory endpoints focus on demographic variables associated with IOP fluctuation changes.

Efficacy and Safety of a Releasable Intraluminal Suture Technique to Reduce Hypotony Following Glaucoma Surgery Using the Preserflo Device

Glaucoma is a common and irreversible disease of the optic nerve. It is the second leading cause of blindness worldwide. Glaucoma can be treated with medication, laser therapy, or surgery; the latter is often necessary. Traditional surgeries are invasive and carry a high rate of complications (hypotony, endophthalmitis, cataracts, etc.). Consequently, several types of micro-invasive surgeries (MIGS) and less invasive but effective surgeries, LIGS, have been developed to reduce surgical risks while maintaining effectiveness in lowering intraocular pressure (IOP). PRESERFLO is a drainage system less than 1 mm thick that regulates the outflow of aqueous humor from the eye. It is made of a soft, flexible biomaterial that conforms to the curvature of the eye. This biomaterial does not trigger a negative immune response. PRESERFLO is an example of a recently developed, powerful LIGS procedure (with preliminary results demonstrating efficacy and safety). PRESERFLO is already in use in France (marketing authorization and CE marking obtained) and is covered by social security. This technique is highly effective in lowering IOP, but it may be associated with hypotony, although less frequently than with trabeculectomy. The use of a releasable suture placed inside the Preserflo to limit drainage and, consequently, reduce the risk of hypotony has been described with good results in preliminary studies. Nevertheless, it is necessary to evaluate the efficacy and safety of this technical modification in a randomized, prospective clinical trial to better understand whether this modification is beneficial for improving the treatment of patients with glaucoma.

Glaucoma Screening to Enhance At-Risk Californians' Health

The vast majority of glaucoma cases in the United States go undetected and untreated until the late stages of the disease. Open-angle glaucoma is a progressive condition that is asymptomatic in its early to moderate stages and may be amenable to screening through telemedicine-based approaches. This study is a randomized trial to evaluate whether glaucoma screening with established tests (e.g., optical coherence tomography, fundus photography, and tonometry) is more effective for detecting undiagnosed glaucoma cases compared to education alone or delayed intervention.

Optic Nerve Head Strain in Non-glaucoma Subjects

Persons who do not have glaucoma will have pictures taken of the optic nerve with a standard camera before and 2 weeks after starting to take a daily glaucoma eye drop to lower eye pressure. These data will be used to compare to the same procedure performed with glaucoma patients to study how glaucoma injures the eye.