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

NCT05713981 | Completed

• 1 other identifier: 2022-1283-EXP
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Meibomian Gland Dysfunction

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• 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.

• 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.

• 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.

• 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.

• 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.

Other Outcomes (2)

• Change in High Contrast Visual Acuity

  This test will occur prior to the intervention (Meibomian gland expression) and immediately after this intervention.

• Change in Small Letter Contrast Sensitivity

  This test will occur prior to the intervention (Meibomian gland expression) and immediately after this intervention.

Study Arms (1)

non-invasive Meibomian gland (MG) expression

EXPERIMENTAL

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

Interventions

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.

non-invasive Meibomian gland (MG) expression

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Under the age of 18
• Individuals currently using prescription eye medications for dry eye / MGD / inflammation / Infections or any other treatments.

Sponsors & Collaborators

• University of the Incarnate Word: lead

Study Sites (1)

University of the Incarnate Word Rosenberg School of Optometry

San Antonio, Texas, 78229, United States

Location

Related Publications (5)

• 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.

  PMID: 32618024 BACKGROUND

• 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.

  PMID: 31116166 BACKGROUND

• 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.

  PMID: 15894874 BACKGROUND

• 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.

  PMID: 29055359 BACKGROUND

• 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.

  PMID: 33534375 BACKGROUND

MeSH Terms

Conditions

Meibomian Gland Dysfunction

Interventions

Gene Expression

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Genetic Phenomena

Study Officials

• Jeffery Rabin, OD, PhD

  University of the Incarnate Word

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Assistant Dean for Graduate Studies, Research and Assessment and Chief, Visual Neurophysiology Service

Study Record Dates

• First Submitted: December 29, 2022
• First Posted: February 6, 2023
• Study Start: March 1, 2023
• Primary Completion: June 8, 2023
• Study Completion: June 8, 2023
• Last Updated: June 26, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will become available upon conclusion of the study and for approximately 1 year.

Locations

US (1)