Effect of Aqueous-Deficient Dry Eye on Lipid Layer Thickness Measurements
Overview
- Phase
- Not Applicable
- Intervention
- 3% diquafosol eyedrops
- Conditions
- Tear
- Sponsor
- Yonsei University
- Enrollment
- 152
- Locations
- 1
- Primary Endpoint
- Average LLT (LLTave)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
Importance: Lipid layer thickness (LLT) reflects the lipid components of tear film, but is affected by the mucocutaneous components. This study investigated the therapeutic effect of the treatments for aqueous-deficient dry eye (ADDE) on LLT.
Objective: To investigate the effect of ADDE and its treatments on LLT measurements by tear interferometry.
Design, Setting, and Participants: This prospective comparative interventional study included 152 eyes from 152 patients with ADDE.
Interventions: Participants were classified into four groups: control group (Group 1), 3% diquafosol group (Group 2), punctal plug insertion group (Group 3), and combined treatment group (Group 4).
Main Outcomes and Measures: Average LLT (LLTave) was measured using a LipiView® II tear interferometer at baseline and one month after treatments.
Investigators
Kyoung Yul Seo
Prof.
Yonsei University
Eligibility Criteria
Inclusion Criteria
- •presence of one or more subjective symptoms of DED, including eye dryness, foreign body sensation, irritation, burning, blurred vision, and pain.
- •tear meniscus height (TMH) of \<200 µm for aqueous deficiency measured using Keratograph 5M® (Oculus Optikgeräte GmbH, Wetzlar, Germany).
- •evidence of corneal and/or conjunctival damage on slit-lamp biomicroscopy with fluorescein staining.
Exclusion Criteria
- •acute and chronic ocular surface diseases that affect DED, including infection, allergy, and autoimmune disease, and that interfere with tear interferometric measurements, such as corneal opacity and pterygium, were excluded.
- •a history of the use of contact lens, known systemic diseases such as Sjögren's syndrome, Stevens-Johnson syndrome, and ocular graft-versus-host disease.
- •any medical/surgical history related to tear production and tear function except that in the study protocol were excluded.
- •Hypersecretory meibomian gland dysfunction (MGD)
- •When both eyes of a patient could be included, an eye with the lower TMH was selected.
Arms & Interventions
Group 2
3% diquafosol eye drops 6 times / day
Intervention: 3% diquafosol eyedrops
Group 3
Punctal plug insertion, lower eyelid
Intervention: Silicone punctal plug insertion
Group 4
3% diquafosol eye drops 6 times / day + Punctal plug insertion, lower eyelid
Intervention: 3% diquafosol eyedrops
Group 4
3% diquafosol eye drops 6 times / day + Punctal plug insertion, lower eyelid
Intervention: Silicone punctal plug insertion
Outcomes
Primary Outcomes
Average LLT (LLTave)
Time Frame: Baseline and one month after 1 month of treatments
LLT was measured using the LipiView® II tear interferometer (Johnson \& Johnson, New Brunswick, New Jersey, USA). The tear interferometer automatically records 20-second videos reflecting the TFLL on the inferior cornea. Simultaneously, the quantified LLT is measured over time in the interferometric color unit (ICU). One ICU corresponds to approximately 1 nm of LLT. The LipiView® II interferometer provides the average, maximum, and minimum LLT values. The average LLT (LLTave) reflects the LLT value at the stable phase of the TFLL spreading or equilibrium state.