Scleral Indentation Instruments for Reducing Eye Exam Discomfort

Recruiting at 1 trial location

Overseen By Parampal Grewal

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Must not be taking: Analgesics

Disqualifiers: Monocular, Media opacity, Oculodynia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

75 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those who are currently using pain medications.

What data supports the effectiveness of the treatment Scleral Indentation for reducing eye exam discomfort?

The research on scleral lenses, which are similar to scleral indentation instruments, shows that they can be worn comfortably by patients and are associated with positive visual and physiological outcomes. This suggests that scleral indentation instruments might also be effective in reducing discomfort during eye exams. ^{1 2 3 4 5}

Is scleral indentation safe for humans?

Research on scleral indentation shows that it can temporarily increase eye pressure during the procedure, but there is no indication of long-term harm. It has been used safely in eye exams and surgeries, although specific safety data for all conditions may not be available. ^{4 6 7 8 9}

How does scleral indentation differ from other treatments for eye exam discomfort?

Scleral indentation is unique because it involves gently pressing on the white part of the eye (sclera) to help doctors see the retina better during an eye exam, which can improve diagnosis and management of retinal issues. Unlike other treatments that might focus on medication or surgery, this technique is a physical method that enhances visualization without the need for drugs. ^{7 10 11 12 13}

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion Criteria

I have symptoms due to the gel inside my eye pulling away from the retina.

Exclusion Criteria

Media opacity which precludes view of the peripheral retina

Inadequate examination (cooperation with examination, inability to achieve all directions of gaze)

Previous scleral indented examination poorly tolerated

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Examination

Patients undergo scleral depression examination using different instruments to assess patient comfort and physician proficiency

1 day

1 visit (in-person)

Follow-up

Participants are monitored for any adverse effects and to collect survey responses on pain and proficiency

1 week

Treatment Details

Interventions

• Scleral Indentation

Trial Overview 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.

Participant Groups

Group I: Group A Active Control 2 Interventions

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

Group II: Group B Active Control 2 Interventions

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

Group III: Group C Active Control 2 Interventions

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

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Alberta Retina Consultant

Collaborator

Trials

2

Recruited

130+

University of Toronto

Collaborator

Trials

739

Recruited

1,125,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Intra-ocular pressure variation associated with the wear of scleral lenses of different diameters. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Effect of Scleral Contact Lens Size and Duration of Wear on Intraocular Pressure. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Alignment of a wavefront-guided scleral lens correction in the presence of a lens capsulotomy. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Modern scleral lenses part II: patient satisfaction. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Visual and physiological outcomes of scleral lens wear. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Central Corneal Edema with Scleral-Lens Wear. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Variable indenter to modify indentation during biomicroscopy of the peripheral fundus. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Influence of the scleral indentation technique on the re-detachment rate following retinal detachment surgery. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Corneal topographic changes and induced astigmatism resulting from superior and temporal scleral pocket incisions. [2006]

10. United States pubmed.ncbi.nlm.nih.gov

Scleral depression. [2005]

11. France pubmed.ncbi.nlm.nih.gov

[Effect of scleral indentation on the corneal topography and the axial length after retinal detachment surgery. A prospective study in 30 cases]. [2006]

12. United States pubmed.ncbi.nlm.nih.gov

Scleral Transillumination With Digital Heads-Up Display: A Novel Technique for Visualization During Vitrectomy Surgery. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

The technique of scleral indentation. [2004]