CompletedNot Applicable

Diamond Bur Microblepharoexfoliation, Intense Pulse Light and Meibomian Gland Expression for Evaporative Dry Eye

Spain70 participantsStarted 2022-04-01

Plain-language summary

The goal of this clinical trial is to assess the efficacy and safety of microblepharoeexfoliation (MBE), intense pulse light (IPL) and meibomian gland expression (MGX) combination in patients with meibomian gland dysfunction (MGD). The main question it aims to answer are: * Does MBE-IPL-MGX treatment improve dry eye symptoms? * Does MBE-IPL-MGX treatment improve dry eye signs? Participants were assigned to receive either three sessions of MBE-IPL-MGX treatment and home-based therapy (treatment group) or home-based therapy alone (control group). The investigators will compare both groups to see if MBE-IPL-MGX treatment is superior to home-based therapy.

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age ≥ 18 years old
. DED diagnosis according to DEWS II meeting one of the following conditions: (2.1) ocular surface disease index (OSDI) score ≥ 13; (2.2) NIBUT \< 10 seconds; and (2.3) ocular surface staining with \> 5 or 9 corneal or conjunctival stains, respectively.
. MGD diagnosis according to the international workshop on MGD meeting two of the following conditions: (3.1) irregularity of the eyelid margin or mucocutaneous junction; (3.2) vascularity of the eyelid margin; (3.3) plugged or capped Meibomian gland orifices; (3.4) Meibomian gland atrophy; or (3.5) decreased meibum quality and quantity

Exclusion criteria

. Skin pathologies that prevent IPL treatment
. All corneal disorders that affect diagnostic tests, such as: (2.1) active corneal infections; and (2.2) corneal dystrophies.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Ocular surface disease index (OSDI) questionnaire.

Timeframe: Change from Baseline OSDI at 2 months.

Tear meniscus height (TMH)

Timeframe: Change from Baseline TMH at 2 months.

Tear meniscus area (TMA)

Timeframe: Change from Baseline TMA at 2 months.

Noninvasive tear film break-up time (NIBUT).

Timeframe: Change from Baseline NIBUT at 2 months.

Lipid Layer Grade (LLG)

Timeframe: Change from Baseline LLG at 2 months.

Ciliary hyperemia

Timeframe: Change from Baseline Ciliary Hyperemia at 2 months.

Conjunctival hyperemia

Timeframe: Change from Baseline Conjunctival Hyperemia at 2 months.

Trial details

NCT IDNCT05857579

SponsorUniversity of Seville

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-11-01

View on ClinicalTrials.gov More Dry Eye Disease trials