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

Meibomian Gland Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05713981
• Other study ID #: 2022-1283-EXP
• Status: Completed
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: June 8, 2023

Study information

• Verified date: June 2023
• Source: University of the Incarnate Word
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 8, 2023
• Est. primary completion date: June 8, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Meibomian Gland Dysfunction

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.

Locations

Country	Name	City	State
United States	University of the Incarnate Word Rosenberg School of Optometry	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of the Incarnate Word

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.