Clinical trial NCT05713981: 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
Overall status: COMPLETED
Phase: NA
Conditions: Meibomian Gland Dysfunction
Lead sponsor: University of the Incarnate Word
Sponsor class: OTHER
First posted: 2023-02-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Change in Cone Contrast Sensitivity on the Cone Contrast Test (CCT, Innova Systems, Inc.)
timeFrame: This test will occur prior to the intervention (Meibomian gland expression) and immediately after this intervention.
measure: Change in Response Time on Cone Contrast Test (CCT, Innova Systems, Inc.)
timeFrame: This test will occur prior to the intervention (Meibomian gland expression) and immediately after this intervention.
Secondary outcomes:
measure: Change in Black White Contrast Sensitivity (Innova Systems, Inc)
timeFrame: This test will occur prior to the intervention (Meibomian gland expression) and immediately after this intervention.
measure: Change in Response Time on Black White Contrast Sensitivity Test (Innova Systems, Inc) Response Time
timeFrame: This test will occur prior to the intervention (Meibomian gland expression) and immediately after this intervention.
measure: Change in Visual Acuity Test at Low Contrast (Innova Systems, Inc)
timeFrame: This test will occur prior to the intervention (Meibomian gland expression) and immediately after this intervention.
measure: Change in Response Time on Visual Acuity Test at Low Contrast (Innova Systems, Inc)
timeFrame: This test will occur prior to the intervention (Meibomian gland expression) and immediately after this intervention.
measure: Change in Sensitivity on Cone Contrast Color Naming test (CCNT)
timeFrame: This test will occur prior to the intervention (Meibomian gland expression) and immediately after this intervention.
measure: Change in Color Naming Accuracy on Cone Contrast Color Naming test (CCNT)
timeFrame: This test will occur prior to the intervention (Meibomian gland expression) and immediately after this intervention.
Other outcomes:
measure: Change in High Contrast Visual Acuity
timeFrame: This test will occur prior to the intervention (Meibomian gland expression) and immediately after this intervention.
measure: Change in Small Letter Contrast Sensitivity
timeFrame: This test will occur prior to the intervention (Meibomian gland expression) and immediately after this intervention.
Locations:
city: San Antonio
country: United States
facility: University of the Incarnate Word Rosenberg School of Optometry
state: Texas
Study officials:
affiliation: University of the Incarnate Word
name: Jeffery Rabin, OD, PhD
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.