PainNCT06683209
Optimizing Patient's Comfort During Scleral Indentation
A study testing Schocket scleral depressor, Josephberg-Besser and Cotton tip applicator in people with Pain, run by University of Alberta at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Schocket scleral depressor, Josephberg-Besser and Cotton tip applicator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Jul 2027to 30 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Symptomatic posterior vitreous detachment with or without vitreoretinal pathology
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites
Alberta Retina Consultant
Edmonton, Alberta, T5H 0X5
Mathieu Carriere, MD, FRCSC, (780) 448-1801, mcarrie2@ualberta.ca
Sunnybrook Hospital
Toronto, Ontario, M4N 3M5
Kenneth T. Eng, MD, FRCSC, (416) 480-4762, Kenneth.Eng@sunnybrook.ca
About this study
Official title: Comparison of Scleral Indentation Instruments and Impact on Patient Comfort
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.
Read more
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.
Read the detailed description
Background The scleral depression exam is an important technique for evaluating the retinal periphery during indirect ophthalmoscopy. Despite the advent of ultra-widefield fundus imaging, scleral depression provides greater sensitivity in detecting peripheral lesions, such as retinal tears. It was found that 11% of retinal tears were missed when employing non-contact slit-lamp examination, compared to indirect ophthalmoscopy with scleral depression, and a scleral depression exam is widely considered the gold standard for ruling out retinal tears. While there is no international consensus, the preferred practice guideline (American Academy of Ophthalmology) for assessing peripheral vitreoretinal pathology is by indirect ophthalmoscopy combined with scleral depression.
There are a variety of ophthalmic instruments that an eye care professional may use to perform scleral depression. While the exam is uncomfortable, there is a lack of studies comparing patient comfort with different instruments. In this prospective study, we will compare subjective patient pain scores using the Schocket scleral depressor, the Josephberg-Besser scleral depressor, and the cotton-tipped applicator.
Purpose To assess patient pain scores for three common scleral indentation devices and determine which is most comfortable for patients.
Objective / Hypothesis Based on clinical experience, the hypothesis is that the Josephberg-Besser scleral depressor causes less discomfort due to its design.
Study Design Prospective comparative analysis.
Methods Patients will be recruited at two tertiary referral centers (Alberta Retinal Consultants, Edmonton, Alberta, and Sunnybrook Hospital, Department of Ophthalmology \& Vision Sciences, Toronto, Ontario) upon consent to participate. Subject identification will be based on the referral indication (symptomatic posterior vitreous detachment with or without vitreoretinal pathology) and the absence of exclusion criteria (i.e., patients who require a scleral indentation examination based on the presenting symptoms). Patients will then be randomly allocated to one of three groups. Additionally, within each group, the symptomatic eye will be randomized.
Patients will be dilated with 1% tropicamide and 2.5% phenylephrine for 30 minutes. Instillation of local anesthetic drops will be used to eliminate any confounding exposure-related keratalgia or ocular surface irritation. Indirect ophthalmoscopic evaluation of the retinal periphery will be undertaken using the provider's lens of choice (20 or 28-diopter lens). The lens and illumination settings will be kept the same for each eye. A similar amount of time and effort will be spent on both eyes.
Following the examination, both patients and physicians will be asked to provide responses to the survey questions provided (surveys enclosed).
Statistical analysis will be performed using R statistical software. Randomization to treatment will be created using Python programming software.
Exclusions:
Monocular status. Media opacity that 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 indentation examination poorly tolerated.
- Conditions
- Pain
- Being tested
- Schocket scleral depressor, Josephberg-Besser, Cotton tip applicator
- Keywords
- Schocket, Josephberg-Besser, Cotton tip applicator
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Schocket scleral depressorDiagnostic test
Use of this instrument to examine one eye
Josephberg-BesserDiagnostic test
Use of this instrument to examine one eye
Cotton tip applicatorDiagnostic test
Use of this instrument to examine one eye
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | One eye examined with the Schocket scleral depressor, the other eye with the Josephberg-Besser scleral depressor Receives: 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 Receives: 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 Receives: Diagnostic Test: Josephberg-Besser; Diagnostic Test: Cotton tip applicator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Once, directly after completing the scleral depressed examination, on the same day of inclusion in the study.
Secondary outcomes (6)
Ergonomics Ease of use
Physician rate their proficiency with the scleral depressor used
- No difficulty o Some difficulty o Significant difficulty
Measured: Once, directly after completing the scleral depressed examination, on the same day of inclusion in the study.
Performance accessing the visualized area
Physician rate their proficiency with the scleral depressor used
- No difficulty o Some difficulty o Significant difficulty
Measured: Once, directly after completing the scleral depressed examination, on the same day of inclusion in the study.
Quantity of indentation
Physician rate their proficiency with the scleral depressor used. Indentation area of the medium light setting of the ophthalmoscope while using a 28D lens. Small is less than 1/3, medium is between 1/3 and 2/3, large is more than 2/3.
Measured: Once, directly after completing the scleral depressed examination, on the same day of inclusion in the study.
Performance achieving sufficient indentation
Physician rate their proficiency with the scleral depressor used
- No difficulty o Some difficulty o Significant difficulty
Measured: Once, directly after completing the scleral depressed examination, on the same day of inclusion in the study.
Duration of examination
The scleral depressed examination will be timed to ensure a similar duration between each eye
Measured: Time mesure will be during the examination of each eye
Degree of retinal pathology
The physician will annotate his findings based on the number and the type of retinal pathology (tear, hole, lattice, other) found.
Measured: The physician will note his findings right after his examination, while completing his examination survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start1 Jul 2027 (estimated)
- Primary completion30 Jul 2028 (estimated)
- Study completion30 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- In each group, patient receive two different types of scleral depressor, one in each eye.
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto, Alberta Retina Consultant
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06683209
- Sponsor's protocol ID
- Pro00146504
- Status last verified
- Aug 2026
- First submitted
- 31 Oct 2024
- Last updated
- 17 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Scleral Indentation Instruments and Impact on Patient Comfort
- ClinicalTrials.gov ID
- NCT06683209
- Acronym / sponsor ID
- Pro00146504
- Conditions
- Pain
- Keywords
- Schocket, Josephberg-Besser, Cotton tip applicator
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- University of Toronto, Alberta Retina Consultant
- Study start
- 1 Jul 2027 (estimated)
- Primary completion
- 30 Jul 2028 (estimated)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background The scleral depression exam is an important technique for evaluating the retinal periphery during indirect ophthalmoscopy. Despite the advent of ultra-widefield fundus imaging, scleral depression provides greater sensitivity in detecting peripheral lesions, such as retinal tears. It was found that 11% of retinal tears were missed when employing non-contact slit-lamp examination, compared to indirect ophthalmoscopy with scleral depression, and a scleral depression exam is widely considered the gold standard for ruling out retinal tears. While there is no international consensus, the preferred practice guideline (American Academy of Ophthalmology) for assessing peripheral vitreoretinal pathology is by indirect ophthalmoscopy combined with scleral depression.
There are a variety of ophthalmic instruments that an eye care professional may use to perform scleral depression. While the exam is uncomfortable, there is a lack of studies comparing patient comfort with different instruments. In this prospective study, we will compare subjective patient pain scores using the Schocket scleral depressor, the Josephberg-Besser scleral depressor, and the cotton-tipped applicator.
Purpose To assess patient pain scores for three common scleral indentation devices and determine which is most comfortable for patients.
Objective / Hypothesis Based on clinical experience, the hypothesis is that the Josephberg-Besser scleral depressor causes less discomfort due to its design.
Study Design Prospective comparative analysis.
Methods Patients will be recruited at two tertiary referral centers (Alberta Retinal Consultants, Edmonton, Alberta, and Sunnybrook Hospital, Department of Ophthalmology \& Vision Sciences, Toronto, Ontario) upon consent to participate. Subject identification will be based on the referral indication (symptomatic posterior vitreous detachment with or without vitreoretinal pathology) and the absence of exclusion criteria (i.e., patients who require a scleral indentation examination based on the presenting symptoms). Patients will then be randomly allocated to one of three groups. Additionally, within each group, the symptomatic eye will be randomized.
Patients will be dilated with 1% tropicamide and 2.5% phenylephrine for 30 minutes. Instillation of local anesthetic drops will be used to eliminate any confounding exposure-related keratalgia or ocular surface irritation. Indirect ophthalmoscopic evaluation of the retinal periphery will be undertaken using the provider's lens of choice (20 or 28-diopter lens). The lens and illumination settings will be kept the same for each eye. A similar amount of time and effort will be spent on both eyes.
Following the examination, both patients and physicians will be asked to provide responses to the survey questions provided (surveys enclosed).
Statistical analysis will be performed using R statistical software. Randomization to treatment will be created using Python programming software.
Exclusions:
Monocular status. Media opacity that 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 indentation examination poorly tolerated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- In each group, patient receive two different types of scleral depressor, one in each eye.
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Diagnostic Test: Schocket scleral depressor, Diagnostic Test: Josephberg-BesserOne eye examined with the Schocket scleral depressor, the other eye with the Josephberg-Besser scleral depressor |
| Group B | Active comparator | Diagnostic Test: Schocket scleral depressor, Diagnostic Test: Cotton tip applicatorOne eye examined with the Schocket scleral depressor, the other eye with the cotton tip applicator |
| Group C | Active comparator | Diagnostic Test: Josephberg-Besser, Diagnostic Test: Cotton tip applicatorOne eye examined with the cotton tip applicator, the other eye with the Josephberg-Besser scleral depressor |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Symptomatic posterior vitreous detachment with or without vitreoretinal pathology
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Schocket scleral depressorUse of this instrument to examine one eye | Diagnostic test | Group A, Group B |
| Josephberg-BesserUse of this instrument to examine one eye | Diagnostic test | Group A, Group C |
| Cotton tip applicatorUse of this instrument to examine one eye | Diagnostic test | Group B, Group C |
Primary outcome
Pain scale
Time frame: Once, directly after completing the scleral depressed examination, on the same day of inclusion in the study.
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.
6 secondary outcomes
Ergonomics Ease of use
Time frame: Once, directly after completing the scleral depressed examination, on the same day of inclusion in the study.
Performance accessing the visualized area
Time frame: Once, directly after completing the scleral depressed examination, on the same day of inclusion in the study.
Quantity of indentation
Time frame: Once, directly after completing the scleral depressed examination, on the same day of inclusion in the study.
Performance achieving sufficient indentation
Time frame: Once, directly after completing the scleral depressed examination, on the same day of inclusion in the study.
Duration of examination
Time frame: Time mesure will be during the examination of each eye
Degree of retinal pathology
Time frame: The physician will note his findings right after his examination, while completing his examination survey
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Schocket scleral depressor, Josephberg-Besser and Cotton tip applicator in people with Pain, run by University of Alberta at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mathieu Carrière, MD, FRCSC ((780) 448-1801, mcarrie2@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain scale (time frame: Once, directly after completing the scleral depressed examination, on the same day of inclusion in the study.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.