Evaluation of Discomfort Associated With Scleral Depression During Retina Examinations

Study Overview
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Brief Summary
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Scleral depression is an important technique used to examine the peripheral retina but often causes patient discomfort. The goal of this study was to compare levels of discomfort during scleral depression with a Schocket scleral depressor and cotton tipped applicator.

Official Title
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Scleral Depression Pain With Schocket Depressor and Cotton Tipped Applicator: Depression Eye Pain Relief Evaluation Study (DEPRESS)

Conditions
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Retina--Diseases, Retinal Detachment, Retinal Degeneration

Intervention / Treatment
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* Device: Schocket scleral depressor
* Device: Cotton tipped applicator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients who received dilated eye examinations in the retina or general eye clinic Exclusion Criteria: Younger than 18 Pregnant Prior scleral buckle, filtering bleb or underwent any other ocular surgery within the past month

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: The first eye to undergo scleral depression was randomly assigned, then that eye was randomized two either of the scleral depression methods. The contralateral eye then had the alternative method of scleral depression performed.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Schocket Scleral Depressor<br>Scleral Depression with Schocket Scleral Depressor | Device: Cotton tipped applicator<br>* Scleral Depression on eye with cotton tipped applicator<br>|
| Active Comparator: Cotton Tipped Applicator<br>Scleral Depression with Cotton Tipped Applicator | Device: Schocket scleral depressor<br>* Scleral Depression on eye with Schocket scleral depressor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discomfort During Scleral Depression with Schocket Depressor and Cotton Tipped Applicator | Visual Analog Scale (VAS) was used to evaluate pain immediately after scleral depression was completed. The VAS scale used was a 100mm long line with 0 representing no pain at all and 100 representing the worst pain possible. | Pain evaluated immediately scleral depression was completed on the eye | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c | The association of discomfort experienced during scleral depression and the patients hemoglobin A1c. | 1 year | 
| Spherical Equivalent of Glasses Prescription | The association of discomfort experienced during scleral depression and the patients spherical equivalent of their glasses prescription. | 1 day | 
| Age | The association of discomfort experienced during scleral depression and the patients age based on those less than 65 versus those greater than 65 years of age | 1 day | 
| Left Eye vs Right Eye | The association of discomfort experienced during scleral depression and the patients left and right eyes. Of note, each eye had a separate method of scleral depression performed. | 1 day | 
| Retinal pathology | Discomfort during scleral depression in participants with peripheral retinal tears or holes versus patients with no peripheral retinal pathology. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Scleral Depression, Visual Analog Scale, Pain, Discomfort, Schocket Scleral Depressor, Cotton Tipped Applicator, Diabetes