The Impact of Dry Eye Syndrome on Metrics of Low Contrast Vision Before and After Meibomian Gland Expression

Sponsor
University of the Incarnate Word (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05713981
Collaborator
(none)
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Study Details

Study Description

Brief Summary

The study aims to determine the impact of Meibomian Gland Dysfunction (MGD) dry eye on low contrast black/white (luminance) and cone color sensitivity performance and improvement in these functions after in-house non-invasive Meibomian gland (MG) expression.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Meibomian gland (MG) expression
N/A

Detailed Description

This study offers possible benefits from gland expression to patients and subjects in terms of clinical measurements and care associated with meibomian gland dysfunction impacting all age ranges. Prior studies show that these interventions improve dry eye symptoms with intent to improve vision, low contrast color, and B/W vision after intervention in this study.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
The Impact of Dry Eye Syndrome on Novel Metrics of Low Contrast Vision Before and After Therapeutic Meibomian Gland Expression
Anticipated Study Start Date :
Feb 6, 2023
Anticipated Primary Completion Date :
Oct 16, 2023
Anticipated Study Completion Date :
Dec 16, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: non-invasive Meibomian gland (MG) expression

Baseline testing of visual acuity, contrast sensitivity, color vision, and Innova, Inc. cone and B/W low contrast vision will be measured. The intervention will be standard clinical expression of Meibomian superior and inferior glands (MG) using a sterile cotton tip applicator to apply gentle pressure in a rolling motion in the direction of the MGs along the upper and lower eyelid margins to allow oil secretion of the tested eye. One drop of sterile saline will be instilled following the intervention to remove debris. The subject's visual acuity, contrast sensitivity, color vision, and Innova, Inc. cone and B/W low contrast vision will be measured before and after this intervention.

Procedure: Meibomian gland (MG) expression
The procedure is performed with a sterile cotton tip applicator once in the upper and lower eyelids of the subject's choosing.

Outcome Measures

Primary Outcome Measures

  1. Change in Cone Contrast Sensitivity on the Cone Contrast Test (CCT, Innova Systems, Inc.) [This test will occur prior to the intervention (Meibomian gland expression) and immediately after this intervention.]

    This computer test measures the lowest contrast (contrast sensitivity) to see red, green and blue cone specific letters.

  2. Change in Response Time on Cone Contrast Test (CCT, Innova Systems, Inc.) [This test will occur prior to the intervention (Meibomian gland expression) and immediately after this intervention.]

    This computer test measures average response time in seconds to see red, green and blue low contrast letters.

Secondary Outcome Measures

  1. Change in Black White Contrast Sensitivity (Innova Systems, Inc) [This test will occur prior to the intervention (Meibomian gland expression) and immediately after this intervention.]

    This computer test measures the lowest contrast (contrast sensitivity) to see black/white letters.

  2. Change in Response Time on Black White Contrast Sensitivity Test (Innova Systems, Inc) Response Time [This test will occur prior to the intervention (Meibomian gland expression) and immediately after this intervention.]

    This computer test measures average response time in seconds to see low contrast black/white letters

  3. Change in Visual Acuity Test at Low Contrast (Innova Systems, Inc) [This test will occur prior to the intervention (Meibomian gland expression) and immediately after this intervention.]

    This computer test measures the smallest low contrast letters which can be seen.

  4. Change in Response Time on Visual Acuity Test at Low Contrast (Innova Systems, Inc) [This test will occur prior to the intervention (Meibomian gland expression) and immediately after this intervention.]

    This computer test measures average response time in seconds to see low contrast visual acuity letters

  5. Change in Sensitivity on Cone Contrast Color Naming test (CCNT) [This test will occur prior to the intervention (Meibomian gland expression) and immediately after this intervention.]

    This computer test measures the lowest contrast (contrast sensitivity) to see red, green, blue and grey letters.

  6. Change in Color Naming Accuracy on Cone Contrast Color Naming test (CCNT) [This test will occur prior to the intervention (Meibomian gland expression) and immediately after this intervention.]

    This computer test measures the accuracy of naming (number correct) low contrast red, green, blue and grey letters.

Other Outcome Measures

  1. Change in High Contrast Visual Acuity [This test will occur prior to the intervention (Meibomian gland expression) and immediately after this intervention.]

    The Precision Vision, Inc. Super Vision Chart will be used to measure visual acuity (smallest black letters on a white background that can be seen).

  2. Change in Small Letter Contrast Sensitivity [This test will occur prior to the intervention (Meibomian gland expression) and immediately after this intervention.]

    The Precision Vision, Inc. Super Vision Chart will be used to measure the lowest contrast (contrast sensitivity) which can be seen using small (20/25) letters.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Individuals over the age of 18 years

  • Healthy individuals with reported symptoms of dry eye such as burning, stinging, fluctuating vision, inappropriate tearing, and feelings of grittiness particularly with prolonged near work

Exclusion Criteria:
  • Under the age of 18

  • Individuals currently using prescription eye medications for dry eye / MGD / inflammation / Infections or any other treatments.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of the Incarnate Word Rosenberg School of Optometry San Antonio Texas United States 78229

Sponsors and Collaborators

  • University of the Incarnate Word

Investigators

  • Study Chair: Jeffery Rabin, OD, PhD, University of the Incarnate Word

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
JEFFREY CARL RABIN, Professor and Assistant Dean for Graduate Studies, Research and Assessment and Chief, Visual Neurophysiology Service, University of the Incarnate Word
ClinicalTrials.gov Identifier:
NCT05713981
Other Study ID Numbers:
  • 2022-1283-EXP
First Posted:
Feb 6, 2023
Last Update Posted:
Feb 6, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 6, 2023