Scleral Depression Pain With Schocket Depressor and Cotton Tipped Applicator: Depression Eye Pain Relief Evaluation Study (DEPRESS)
Phase: NA
Conditions: Retina--Diseases, Retinal Detachment, Retinal Degeneration
Sponsor: New York City Health and Hospitals Corporation

 
 
Official Tittle: Scleral Depression Pain with Schocket Depressor and Cotton Tipped Applicator: 
Depression Eye Pain Relief Evaluation Study (DEPRESS) 
 
Date: 9/21/19 
Date Created: 9/17/17 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol Title: Depression Eye Pain Relief Evaluation Scale Study (DEPRESS) 
Protocol Identification: JJR 666 
 
Version Date: 9/17/17 
 
Background Information: 
           Scleral depression is a commonly used technique that enhances visualization of the 
peripheral retina and ora serrata. A patient is dilated with 1% tropicamide and 2.5% 
phenylephrine and anesthetized with 0.5% proparacaine to improve comfort and reduce the 
patient's need to blink.  A 20 diopter lens and a binocular indirect ophthalmoscope are used to 
visualize the retina.  Practitioners commonly use a flat double-ended metal scleral depressor 
suchh as the Schocket scleral depressor or a cotton-tip applicator and this preference has 
historically been based on physician's preference.  The scleral depressor is placed 
perpendicularly on the scleral 5mm to 8mm posterior to the limbus as the patient looks in the 
opposite direction allowing a view of the peripheral retina and ora serrata.  The level of patient 
comfort of metal scleral depressors and cotton tip applicators has never been established and 
that is what this study hopes to elucidate. 
          The risks to patients include discomfort and no harms have been documented as long as 
scleral depression is not used on patients that we will exclude from this study (below). 
 
Population/Inclusion Criteria: 
           All patients at Kings County Hospital that will be undergoing scleral depression that are 
over 18 years of age and able to give consent.  Scleral depression is indicated in patients with 
high myopia or peripheral retinal pathology that needs to be viewed or when patients have 
complaints of flashers and/or floaters and peripheral retinal detachments are needed to be ruled 
out. Monocular patients or patients not requiring scleral depression on both eyes will be 
included. 
 
Exclusion Criteria: 
           Patients to be excluded include those under 18 years of age, unable to sign consent for 
themselves, pregnant patients. Scleral depression should not be done on patients with an open 
globe injury, hyphema, a scleral buckle, filtering bleb or recent ocular surgery within the last 
month.   
 
Objectives/Purpose: 
           Determine the level of comfort that patients report using the Visual Analog pain Scale 
(VAS) after the scleral depression procedure using a flat double-ended metal scleral depressor 
or a cotton-tip applicator. 
 
Trial Design: 
This study will be designed as a single blind randomized control trial with crossover of 
the two scleral depression methods. The the patient will be told that there are two separate 
devices for scleral depression but not shown each device prior to its selection. All patients will 
have their pupils dilated with 1% tropicamide and 2.5% phenylephrine 30 minutes prior to scleral 
depression and anesthetized with 0.5% proparacaine will be given immediately prior to scleral 
depression. Patient will be randomly assigned with a random number generator to determine 
the eye that will have scleral depression first, next the method of scleral depression will be 
randomly assigned.  The contralateral eye will then have opposing scleral depression method 
utilized. 

The VAS survey will be given to the patient immediately after the first eye is scleral 
depressed, then after the second eye is depressed they will be given the same VAS survey on a 
separate page so that they cannot see their first pain rating. 
Secondary endpoints will include determining if associated medical problems that they 
have are associated with different levels of pain.  The different VAS means will also be 
compared between the different practitioners and their level of training. 
 
Statistics: 
           A T-test will be conducted to determine the significant between the means. A linear 
regression analysis and multiple regression analysis will be used to look for a correlation with 
the secondary outcomes. 
 
Sample Size 
 
A power analysis with the assumptions that the means will be 2 and 2.5 with a standard 
deviation of 2 and an alpha of 0.05 and a power of 95% requires a sample of 415.  Thus, we 
plan to enroll 208 patients or 416 eyes. 
 
Direct Access to Source Data Documents: 
           Joseph Raevis and the principle investigator will keep that data locked in a cabinet in the 
Kings County Hospital Eye clinic for the duration of the study. 
 
References: 
Dinardo A, Walling P. The Lost Arts of Optometry, Part One: A Refresher on Scleral 
Depression. Review of Optometry. August 15, 2013.