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Procedure
Scleral Indentation Instruments for Reducing Eye Exam Discomfort
N/A
Waitlist Available
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Symptomatic posterior vitreous detachment with or without vitreoretinal pathology
Be older than 18 years old
Must not have
Underlying oculodynia (recent surgery, intraocular inflammation, abnormal intraocular pressure, ocular dysesthesia syndromes)
History of pain-sensitizing conditions or current analgesic use
Timeline
Screening 3 weeks
Treatment Varies
Follow Up before recruiting patients
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to compare the performance and discomfort levels of three commonly used instruments used for examining the retina's periphery in the eye. Patients will be randomly assigned to one of three groups where different instruments
Who is the study for?
This trial is for individuals who need a retinal examination, which involves pressing on the eye's surface (sclera) to view the retina. Participants must be comfortable with random assignment to have one of their eyes tested with either a Schocket scleral depressor, Josephberg-Besser scleral depressor, or cotton tip applicator.
What is being tested?
The study aims to compare three tools used in eye exams: Schocket and Josephberg-Besser scleral depressors, and cotton tip applicators. Patients will have different tools used on each eye randomly to determine which causes less discomfort while being effective for the doctor.
What are the potential side effects?
Potential side effects may include discomfort or pain in the eyes during or after using any of these instruments. The severity can vary depending on individual sensitivity and reaction to pressure applied by each tool.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have symptoms due to the gel inside my eye pulling away from the retina.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have eye pain or discomfort due to recent surgery, inflammation, pressure changes, or sensitivity.
Select...
I have conditions that increase my sensitivity to pain or I'm currently using painkillers.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ once, directly after completing the scleral depressed examination, on the same day of inclusion in the study.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~once, directly after completing the scleral depressed examination, on the same day of inclusion in the study.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pain scale
Secondary study objectives
Degree of retinal pathology
Duration of examination
Ergonomics Ease of use
+3 moreOther study objectives
Depressor routinely used by participating physician
Lens routinely used by participating physician
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Active Control
Group I: Group AActive Control2 Interventions
One eye examined with the Schocket scleral depressor, the other eye with the Josephberg-Besser scleral depressor
Group II: Group BActive Control2 Interventions
One eye examined with the Schocket scleral depressor, the other eye with the cotton tip applicator
Group III: Group CActive Control2 Interventions
One eye examined with the cotton tip applicator, the other eye with the Josephberg-Besser scleral depressor
Find a Location
Who is running the clinical trial?
Alberta Retina ConsultantUNKNOWN
1 Previous Clinical Trials
50 Total Patients Enrolled
1 Trials studying Pain
50 Patients Enrolled for Pain
University of AlbertaLead Sponsor
942 Previous Clinical Trials
434,334 Total Patients Enrolled
7 Trials studying Pain
1,693 Patients Enrolled for Pain
University of TorontoOTHER
725 Previous Clinical Trials
1,115,617 Total Patients Enrolled
7 Trials studying Pain
1,151 Patients Enrolled for Pain