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Completed

NCT Number: NCT04115917

Evaluation of Discomfort Associated With Scleral Depression During Retina Examinations

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Schocket scleral depressor

Device

Scleral Depression on eye with Schocket scleral depressor

Cotton tipped applicator

Device

Scleral Depression on eye with cotton tipped applicator

Primary outcomes

  1. Discomfort During Scleral Depression with Schocket Depressor and Cotton Tipped Applicator

    Time frame: Pain evaluated immediately scleral depression was completed on the eye

    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.

Secondary outcomes

  1. Hemoglobin A1c

    Time frame: 1 year

    The association of discomfort experienced during scleral depression and the patients hemoglobin A1c.

  2. Spherical Equivalent of Glasses Prescription

    Time frame: 1 day

    The association of discomfort experienced during scleral depression and the patients spherical equivalent of their glasses prescription.

  3. Age

    Time frame: 1 day

    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

  4. Left Eye vs Right Eye

    Time frame: 1 day

    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.

  5. Retinal pathology

    Time frame: 1 day

    Discomfort during scleral depression in participants with peripheral retinal tears or holes versus patients with no peripheral retinal pathology.

Sponsors and collaborators

Lead sponsor

New York City Health and Hospitals Corporation

Other

Registry information

Official study title

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

Acronym: DEPRESS

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Oct 4, 2019
Registry last updated
Oct 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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