Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
152 participants
INTERVENTIONAL
2018-08-01
2022-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Group 1
No intervention
No interventions assigned to this group
Group 2
3% diquafosol eye drops 6 times / day
3% diquafosol eyedrops
Diquas® (Santen, Osaka, Japan), six times per day.
Group 3
Punctal plug insertion, lower eyelid
Silicone punctal plug insertion
a silicone punctal occluder (Parasol® Punctal Occluder, BVI, Waltham, Massachusetts, USA), inserted into the lower eyelid
Group 4
3% diquafosol eye drops 6 times / day + Punctal plug insertion, lower eyelid
3% diquafosol eyedrops
Diquas® (Santen, Osaka, Japan), six times per day.
Silicone punctal plug insertion
a silicone punctal occluder (Parasol® Punctal Occluder, BVI, Waltham, Massachusetts, USA), inserted into the lower eyelid
Interventions
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3% diquafosol eyedrops
Diquas® (Santen, Osaka, Japan), six times per day.
Silicone punctal plug insertion
a silicone punctal occluder (Parasol® Punctal Occluder, BVI, Waltham, Massachusetts, USA), inserted into the lower eyelid
Eligibility Criteria
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Inclusion Criteria
2. tear meniscus height (TMH) of \<200 µm for aqueous deficiency measured using Keratograph 5M® (Oculus Optikgeräte GmbH, Wetzlar, Germany).
3. evidence of corneal and/or conjunctival damage on slit-lamp biomicroscopy with fluorescein staining.
Exclusion Criteria
2. 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.
3. any medical/surgical history related to tear production and tear function except that in the study protocol were excluded.
4. Hypersecretory meibomian gland dysfunction (MGD)
* When both eyes of a patient could be included, an eye with the lower TMH was selected.
19 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Kyoung Yul Seo
Prof.
Locations
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Severance Hospital, Yonsei University College of Medicine
Seoul, , South Korea
Countries
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Other Identifiers
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4-2018-0634
Identifier Type: -
Identifier Source: org_study_id
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