Status:
ACTIVE_NOT_RECRUITING
Mechanisms of Light-based Therapies for Dry Eye Disease
Lead Sponsor:
Aston University
Conditions:
Dry Eye Syndromes
Meibomian Gland Dysfunction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Dry eye disease is a common condition affecting millions worldwide and costing millions in healthcare due to reduced work productivity and quality of life. The disruption of oil glands in our eyelids ...
Detailed Description
This study will be a randomized, double-masked, paired-eye clinical study to assess the potential difference in impact between the two treatment modalities. Each eye of the participant will be randomi...
Eligibility Criteria
Inclusion
- Individuals with dry eye disease symptoms (Ocular Surface Disease Index questionnaire (OSDI) score ≥ 13 or Dry Eye Questionnaire (DEQ5) score \> 6) and signs (tear film instability measured with non-invasive tear break-up time \< 10 s or ocular surface damage measured using special dyes placed on the front surface of the eyes that temporarily stains any aggravated or damaged cells: \> 5 corneal spots, \> 9 conjunctival spots or lid margin staining ≥ 2mm in length and ≥ 25% in width) (Wolffsohn et al., 2017)
- Individuals need to also have Meibomian gland dysfunction. The diagnosis of Meibomian gland dysfunction depends on how many of 5 glands in the central lower eyelid can express oil, and the quality of the oil. A diagnosis is made if there is decreased expressibility (grade 1-3 on the Pflugfelder scale) and reduced quality of oil (grade 1-3 on Bron scale). Any presence of gland blockage and/or loss of oil glands grade 2 to grade 4 of either eyelid \[Pult and Reide-Pult, 2013\]) will also justify a diagnosis of Meibomian gland dysfunction
- Age ≥ 18 years, male or female
- Able to provide written consent in English
- Able to attend multiple visits (4 treatment visits) and followed up for 2 weeks and 3 months after final treatment
Exclusion
- Pregnancy
- Contraindications to IPL treatment (Individuals with darker skin types - Fitzpatrick skin type V or VI, photosensitive epilepsy, tattoos, implants, electrical or acoustic prosthetics, semi-permanent make-up, pigmented lesions or skin cancer in the treatment area, pacemakers, use of photosensitising medication the past 3 months or during treatment period)
- Facial or ocular IPL or LLLT treatment within the past 6 months or during study period in addition to those provided in the study
- Use of topical medical eyedrops in the past 3 months or during study period
- Contact lens wear in the past 2 weeks or during study period
- Systemic conditions that can cause dry eye disease or corneal nerve loss including diabetes and Sjögren's syndrome
- Other active ocular surface diseases or history of ocular surgery or corneal infections
- Individuals with 1 eye
Key Trial Info
Start Date :
October 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2025
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT06004895
Start Date
October 25 2023
End Date
October 1 2025
Last Update
July 23 2025
Active Locations (1)
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1
Aston Dry Eye Clinic
Birmingham, West Midlands, United Kingdom, B4 7ET