60200 Participants Needed

Community Eye Screening for Vision Loss Prevention

(VIEW II Trial)

Recruiting at 2 trial locations
VM
KM
Overseen ByKrisianne M Aromin, BS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of California, San Francisco
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find the best way to prevent blindness by comparing two different eye screening programs. One program uses advanced technology, such as OCT (a special eye scan), to screen for conditions like glaucoma and diabetic retinopathy while connecting patients to care. The other program focuses on a basic vision test. Residents aged 50 and older in urban or nearby areas of Bharatpur or Lumbini, accessible by regular vehicles, can participate.

As an unphased trial, this study offers participants the chance to contribute to important research that could enhance eye care for many.

Do I need to stop my current medications for this eye screening trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to consult with the trial coordinators or your doctor for guidance.

What prior data suggests that these screening methods are safe for vision loss prevention?

Research shows that the screening methods used in this trial are generally safe for people.

For checking eye pressure, studies have found that this method is well-tolerated, with various safe devices available for patients. This test is a standard part of eye exams and is considered reliable.

Optical coherence tomography (OCT) serves as another important tool in the trial. This non-invasive imaging technique is widely used to diagnose and monitor eye diseases. Studies confirm that OCT is safe and suitable for most people.

Visual acuity tests, such as reading a Snellen chart, are also safe and commonly used to assess vision. These simple tests involve reading letters from a distance and are part of routine eye exams.

Overall, these screening methods are safe and widely used in eye care. They are designed to detect eye problems without causing harm to patients.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to improve early detection and prevention of vision loss by using a combination of advanced screening techniques. Unlike traditional eye exams that might focus solely on visual acuity, this approach includes measuring intraocular pressure and using optical coherence tomography (OCT) to get detailed images of the retina. These methods allow for a more comprehensive assessment of eye health, potentially catching issues that other standard methods might miss. This could lead to earlier interventions and better outcomes for individuals at risk of vision loss.

What evidence suggests that this trial's screening methods could be effective for preventing vision loss?

Research has shown that optical coherence tomography (OCT), a method used in this trial, is a powerful tool for diagnosing eye diseases. OCT provides clear and detailed images, effectively identifying conditions like glaucoma, diabetic retinopathy, and age-related macular degeneration. Studies have found that OCT accurately detects diseases and reduces the chances of false alarms. Checking eye pressure, another method in this trial, can also help detect glaucoma early, potentially preventing severe vision loss. While vision tests, also part of this trial, are effective for noticing changes in sight, they might not catch all causes of vision loss. Together, these methods can improve early detection and treatment, helping to prevent or slow down vision loss.678910

Who Is on the Research Team?

JK

Jeremy Keenan

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for communities in the catchment areas of Bharatpur Eye Hospital or Lumbini Eye Institute that are reachable by non-4WD vehicles, including urban and peri-urban locations. It aims to include a broad demographic to assess eye health strategies.

Inclusion Criteria

Community level: Located in catchment area of Bharatpur Eye Hospital or Lumbini Eye Institute
Community level: Reachable by non-4WD vehicle
Community level: Urban or peri-urban
See 2 more

Exclusion Criteria

Community level: Local leaders unwilling to participate
I am willing to participate in the trial.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial door-to-door census to assess baseline visual acuity in both study arms

4 weeks
Door-to-door visits

Intensive Screening

Screening with OCT, fundus photography, and intraocular pressure testing for glaucoma, DR, and AMD, followed by enhanced linkage-to-care

Varies
Multiple visits as needed

Follow-up

Repeat visual acuity assessment 9 years later to compare visual acuity between the two arms

9 years
Door-to-door visits

What Are the Treatments Tested in This Trial?

Interventions

  • Active linkage to care
  • Intraocular pressure
  • Optical coherence tomography (OCT)
  • Visual acuity (presenting and pinhole)
Trial Overview The study compares two blindness prevention programs: one using OCT, fundus photography, and pressure testing followed by active care linkage versus another with only visual acuity assessment. The impact on vision will be measured over 9 years.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: ScreeningExperimental Treatment5 Interventions
Group II: Case detectionActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials
2,636
Recruited
19,080,000+

Lumbini Eye Institute and Hospital

Collaborator

Trials
4
Recruited
60,600+

Seva Foundation

Collaborator

Trials
9
Recruited
302,000+

Bharatpur Eye Hospital

Collaborator

Trials
7
Recruited
301,000+

Citations

A Comparative Effectiveness Analysis of Visual Field ...The prevalence of severe visual field loss decreases from 29.1% to 23.9% in screened individuals with glaucoma (Table 4; Figs. 2, 3). Conversely, the prevalence ...
Outcomes of Glaucoma Referrals in Adults Aged 18 to 40 ...In this cohort study, the diagnostic yield of glaucoma referrals was low among adults aged 18 to 40 years with first-time eye examinations.
Leveraging Sight Outcomes Research Collaborative ...These findings highlight the potential value of multi-purpose screening programs, particularly those aligned with primary careโ€“based diabetes ...
The Cost-Effectiveness of an Artificial Intelligence-Based ...AI screening detected glaucoma 1.6 times more effectively than opportunistic case finding, reducing visual impairment by 0.7 months per ...
Results - Primary Care Screening for Ocular Hypertension and ...Medically treated eyes showed improvement in the first 3 years (+0.1 to 0.6 dB), and no change or deterioration thereafter (0.0 to -2.3 dB). The overall ...
How to Measure Intraocular Pressure: An Updated Review of ...The authors review the various devices currently in use for the measurement of intraocular pressure (IOP), highlighting the main advantages and limits of the ...
A Novel Contact Lens Sensor System for Continuous ...A novel contact lens sensor system for continuous intraocular pressure monitoring: evaluation of accuracy in human eyes.
Review article Intraocular pressure measurement: A reviewIntraocular pressure measurement focuses on three methods: transpalpebral measurement, tonometry, and manometry.
Eye Pressure TestingAs part of a complete eye exam, your ophthalmologist will measure your eye pressure. This pressure check is called tonometry.
Overnight Safety Evaluation of a Multi-Pressure Dial in ...Abstract. Purpose. To investigate the safety and tolerability of the multi-pressure dial (MPD) worn overnight for seven consecutive days.
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