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Completed

NCT Number: NCT05713981

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

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.

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Key information

Conditions

Meibomian Gland Dysfunction Eye Diseases Eyelid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of the Incarnate Word Rosenberg School of Optometry

San Antonio, Texas, 78229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Meibomian gland (MG) expression

Procedure

The procedure is performed with a sterile cotton tip applicator once in the upper and lower eyelids of the subject's choosing.

Primary outcomes

  1. Change in Cone Contrast Sensitivity on the Cone Contrast Test (CCT, Innova Systems, Inc.)

    Time frame: 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.)

    Time frame: 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 outcomes

  1. Change in Black White Contrast Sensitivity (Innova Systems, Inc)

    Time frame: 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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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 outcomes

  1. Change in High Contrast Visual Acuity

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of the Incarnate Word

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 6, 2023
Registry last updated
Jun 26, 2023

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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