Back to resultsThe Impact of Dry Eye Syndrome on Metrics of Low Contrast Vision Before and After Meibomian Gland Expression
Primary Purpose
Meibomian Gland Dysfunction
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Meibomian gland (MG) expression
Sponsored by
About this trial
This is an interventional supportive care trial for Meibomian Gland Dysfunction
Eligibility Criteria
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.
Sites / Locations
- University of the Incarnate Word Rosenberg School of Optometry
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
non-invasive Meibomian gland (MG) expression
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Change in Black White Contrast Sensitivity (Innova Systems, Inc)
This computer test measures the lowest contrast (contrast sensitivity) to see black/white letters.
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
Change in Visual Acuity Test at Low Contrast (Innova Systems, Inc)
This computer test measures the smallest low contrast letters which can be seen.
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
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.
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.
Full Information
NCT ID
NCT05713981
First Posted
December 29, 2022
Last Updated
June 23, 2023
Sponsor
University of the Incarnate Word
1. Study Identification
Unique Protocol Identification Number
NCT05713981
Brief Title
The Impact of Dry Eye Syndrome on Metrics of Low Contrast Vision Before and After Meibomian Gland Expression
Official Title
The Impact of Dry Eye Syndrome on Novel Metrics of Low Contrast Vision Before and After Therapeutic Meibomian Gland Expression
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
June 8, 2023 (Actual)
Study Completion Date
June 8, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of the Incarnate Word
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meibomian Gland Dysfunction
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
non-invasive Meibomian gland (MG) expression
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Meibomian gland (MG) expression
Intervention Description
The procedure is performed with a sterile cotton tip applicator once in the upper and lower eyelids of the subject's choosing.
Primary Outcome Measure Information:
Title
Change in Cone Contrast Sensitivity on the Cone Contrast Test (CCT, Innova Systems, Inc.)
Description
This computer test measures the lowest contrast (contrast sensitivity) to see red, green and blue cone specific letters.
Time Frame
This test will occur prior to the intervention (Meibomian gland expression) and immediately after this intervention.
Title
Change in Response Time on Cone Contrast Test (CCT, Innova Systems, Inc.)
Description
This computer test measures average response time in seconds to see red, green and blue low contrast letters.
Time Frame
This test will occur prior to the intervention (Meibomian gland expression) and immediately after this intervention.
Secondary Outcome Measure Information:
Title
Change in Black White Contrast Sensitivity (Innova Systems, Inc)
Description
This computer test measures the lowest contrast (contrast sensitivity) to see black/white letters.
Time Frame
This test will occur prior to the intervention (Meibomian gland expression) and immediately after this intervention.
Title
Change in Response Time on Black White Contrast Sensitivity Test (Innova Systems, Inc) Response Time
Description
This computer test measures average response time in seconds to see low contrast black/white letters
Time Frame
This test will occur prior to the intervention (Meibomian gland expression) and immediately after this intervention.
Title
Change in Visual Acuity Test at Low Contrast (Innova Systems, Inc)
Description
This computer test measures the smallest low contrast letters which can be seen.
Time Frame
This test will occur prior to the intervention (Meibomian gland expression) and immediately after this intervention.
Title
Change in Response Time on Visual Acuity Test at Low Contrast (Innova Systems, Inc)
Description
This computer test measures average response time in seconds to see low contrast visual acuity letters
Time Frame
This test will occur prior to the intervention (Meibomian gland expression) and immediately after this intervention.
Title
Change in Sensitivity on Cone Contrast Color Naming test (CCNT)
Description
This computer test measures the lowest contrast (contrast sensitivity) to see red, green, blue and grey letters.
Time Frame
This test will occur prior to the intervention (Meibomian gland expression) and immediately after this intervention.
Title
Change in Color Naming Accuracy on Cone Contrast Color Naming test (CCNT)
Description
This computer test measures the accuracy of naming (number correct) low contrast red, green, blue and grey letters.
Time Frame
This test will occur prior to the intervention (Meibomian gland expression) and immediately after this intervention.
Other Pre-specified Outcome Measures:
Title
Change in High Contrast Visual Acuity
Description
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).
Time Frame
This test will occur prior to the intervention (Meibomian gland expression) and immediately after this intervention.
Title
Change in Small Letter Contrast Sensitivity
Description
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.
Time Frame
This test will occur prior to the intervention (Meibomian gland expression) and immediately after this intervention.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffery Rabin, OD, PhD
Organizational Affiliation
University of the Incarnate Word
Official's Role
Study Chair
Facility Information:
Facility Name
University of the Incarnate Word Rosenberg School of Optometry
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
32618024
Citation
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.
Results Reference
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PubMed Identifier
31116166
Citation
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.
Results Reference
background
PubMed Identifier
15894874
Citation
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.
Results Reference
background
PubMed Identifier
29055359
Citation
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.
Results Reference
background
PubMed Identifier
33534375
Citation
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.
Results Reference
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Learn more about this trial
The Impact of Dry Eye Syndrome on Metrics of Low Contrast Vision Before and After Meibomian Gland Expression
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