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

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

Study Overview

• Status: Completed
• Conditions: Meibomian Gland Dysfunction
• Intervention / Treatment: Procedure: Meibomian gland (MG) expression

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • University of the Incarnate Word Rosenberg School of Optometry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Cone Contrast Sensitivity on the Cone Contrast Test (CCT, Innova Systems, Inc.)	This computer test measures the lowest contrast (contrast sensitivity) to see red, green and blue cone specific letters.	This test will occur prior to the intervention (Meibomian gland expression) and immediately after this intervention.
Change in Response Time on Cone Contrast Test (CCT, Innova Systems, Inc.)	This computer test measures average response time in seconds to see red, green and blue low contrast letters.	This test will occur prior to the intervention (Meibomian gland expression) and immediately after this intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Black White Contrast Sensitivity (Innova Systems, Inc)	This computer test measures the lowest contrast (contrast sensitivity) to see black/white letters.	This test will occur prior to the intervention (Meibomian gland expression) and immediately after this intervention.
Change in Response Time on Black White Contrast Sensitivity Test (Innova Systems, Inc) Response Time	This computer test measures average response time in seconds to see low contrast black/white letters	This test will occur prior to the intervention (Meibomian gland expression) and immediately after this intervention.
Change in Visual Acuity Test at Low Contrast (Innova Systems, Inc)	This computer test measures the smallest low contrast letters which can be seen.	This test will occur prior to the intervention (Meibomian gland expression) and immediately after this intervention.
Change in Response Time on Visual Acuity Test at Low Contrast (Innova Systems, Inc)	This computer test measures average response time in seconds to see low contrast visual acuity letters	This test will occur prior to the intervention (Meibomian gland expression) and immediately after this intervention.
Change in Sensitivity on Cone Contrast Color Naming test (CCNT)	This computer test measures the lowest contrast (contrast sensitivity) to see red, green, blue and grey letters.	This test will occur prior to the intervention (Meibomian gland expression) and immediately after this intervention.
Change in Color Naming Accuracy on Cone Contrast Color Naming test (CCNT)	This computer test measures the accuracy of naming (number correct) low contrast red, green, blue and grey letters.	This test will occur prior to the intervention (Meibomian gland expression) and immediately after this intervention.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in High Contrast Visual Acuity	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).	This test will occur prior to the intervention (Meibomian gland expression) and immediately after this intervention.
Change in Small Letter Contrast Sensitivity	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.	This test will occur prior to the intervention (Meibomian gland expression) and immediately after this intervention.

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Gao Y, Liu R, Liu Y, Ma B, Yang T, Hu C, Qi H. Optical quality in patients with dry eye before and after treatment. Clin Exp Optom. 2021 Jan;104(1):101-106. doi: 10.1111/cxo.13111.
• Szczotka-Flynn LB, Maguire MG, Ying GS, Lin MC, Bunya VY, Dana R, Asbell PA; Dry Eye Assessment and Management (DREAM) Study Research Group. Impact of Dry Eye on Visual Acuity and Contrast Sensitivity: Dry Eye Assessment and Management Study. Optom Vis Sci. 2019 Jun;96(6):387-396. doi: 10.1097/OPX.0000000000001387.
• Narayanan S, Miller WL, Prager TC, Jackson JA, Leach NE, McDermott AM, Christensen MT, Bergmanson JP. The diagnosis and characteristics of moderate dry eye in non-contact lens wearers. Eye Contact Lens. 2005 May;31(3):96-104. doi: 10.1097/01.icl.0000140907.45705.e2.
• Thulasi P, Djalilian AR. Update in Current Diagnostics and Therapeutics of Dry Eye Disease. Ophthalmology. 2017 Nov;124(11S):S27-S33. doi: 10.1016/j.ophtha.2017.07.022.
• Yeh TN, Lin MC. Meibomian Gland Contrast Sensitivity and Specificity in the Diagnosis of Lipid-deficient Dry Eye: A Pilot Study. Optom Vis Sci. 2021 Feb 1;98(2):121-126. doi: 10.1097/OPX.0000000000001636.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): June 8, 2023
• Study Completion (Actual): June 8, 2023

Study Registration Dates

• First Submitted: December 29, 2022
• First Submitted That Met QC Criteria: February 1, 2023
• First Posted (Actual): February 6, 2023

Study Record Updates

• Last Update Posted (Actual): June 26, 2023
• Last Update Submitted That Met QC Criteria: June 23, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eyelid Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Meibomian Gland Dysfunction
• Other Study ID Numbers: 2022-1283-EXP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Share IPD will facilitate data analysis and understanding for current and future research. We will share outcome and results and potentially present to local, national, and international faculty during conferences.
• IPD Sharing Time Frame: Data will become available upon conclusion of the study and for approximately 1 year.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No