Optimizing Patient's Comfort During Scleral Indentation

NCT06683209 | Not Yet Recruiting

• 1 other identifier: Pro00146504
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 2

Brief Summary

The scleral depression exam is an important routine technique for evaluating the retinal periphery for various reasons. During this examination, an instrument is used to bring the anterior part of the retina into the physician's field of view. The downside of this technique is the discomfort it may cause the patient. Different instruments can be used to depress the sclera. The objective of this research is to compare three commonly used scleral depressors based on their performance for the ophthalmologist and the discomfort they subjectively induce in patients. Patients will be randomly allocated to one of three examination groups: Group A: One eye examined with the Schocket scleral depressor, the other eye with the Josephberg-Besser scleral depressor. Group B: One eye examined with the Schocket scleral depressor, the other eye with the cotton-tip applicator. Group C: One eye examined with the cotton-tip applicator, the other eye with the Josephberg-Besser scleral depressor.

Conditions

Pain

Keywords

Schocket; Josephberg-Besser; Cotton tip applicator

Outcome Measures

Primary Outcomes (1)

• Pain scale

  Patient rate their pain with the Wong-Baker Faces scale for each eye, from 0 to 10, 0 being the absence of pain and 10 being the worst imaginable pain.

  Once, directly after completing the scleral depressed examination, on the same day of inclusion in the study.

Secondary Outcomes (6)

• Ergonomics Ease of use

  Once, directly after completing the scleral depressed examination, on the same day of inclusion in the study.

• Performance accessing the visualized area

  Once, directly after completing the scleral depressed examination, on the same day of inclusion in the study.

• Quantity of indentation

  Once, directly after completing the scleral depressed examination, on the same day of inclusion in the study.

• Performance achieving sufficient indentation

  Once, directly after completing the scleral depressed examination, on the same day of inclusion in the study.

• Duration of examination

  Time mesure will be during the examination of each eye

Other Outcomes (2)

• Depressor routinely used by participating physician

  Before recruiting patients

• Lens routinely used by participating physician

  Before recruiting patients

Study Arms (3)

Group A

ACTIVE COMPARATOR

One eye examined with the Schocket scleral depressor, the other eye with the Josephberg-Besser scleral depressor

Diagnostic Test: Schocket scleral depressor; Diagnostic Test: Josephberg-Besser

Group B

ACTIVE COMPARATOR

One eye examined with the Schocket scleral depressor, the other eye with the cotton tip applicator

Diagnostic Test: Schocket scleral depressor; Diagnostic Test: Cotton tip applicator

Group C

ACTIVE COMPARATOR

One eye examined with the cotton tip applicator, the other eye with the Josephberg-Besser scleral depressor

Diagnostic Test: Josephberg-Besser; Diagnostic Test: Cotton tip applicator

Interventions

Schocket scleral depressor DIAGNOSTIC_TEST

Use of this instrument to examine one eye

Group A; Group B

Josephberg-Besser DIAGNOSTIC_TEST

Use of this instrument to examine one eye

Group A; Group C

Cotton tip applicator DIAGNOSTIC_TEST

Use of this instrument to examine one eye

Group B; Group C

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic posterior vitreous detachment with or without vitreoretinal pathology

You may not qualify if:

• Monocular status.
• Media opacity which precludes view of the peripheral retina.
• Inadequate examination (cooperation with examination, inability to achieve all directions of gaze).
• Underlying oculodynia (recent surgery, intraocular inflammation, abnormal intraocular pressure, ocular dysesthesia syndromes (ocular, adnexal or orbital).
• History of pain-sensitizing conditions or current analgesic use.
• Previous scleral indented examination poorly tolerated.

Sponsors & Collaborators

• University of Alberta: lead
• University of Toronto: collaborator
• Alberta Retina Consultant: collaborator

Study Sites (2)

Alberta Retina Consultant

Edmonton, Alberta, T5H 0X5, Canada

Location

Sunnybrook Hospital

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mathieu Carrière, MD, FRCSC

CONTACT

(780) 448-1801; mcarrie2@ualberta.ca

Parampal Grewal

CONTACT

(780) 448-1801; parampal@ualberta.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In each group, patient receive two different types of scleral depressor, one in each eye.

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 12, 2024
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: August 1, 2025

Record last verified: 2025-07

Locations

CA (2)