CompletedNot Applicable

Modified Tarsorrhaphy vs Gold Weight Implant for Paralytic Lagophthalmos in Leprosy Patients

Indonesia19 participantsStarted 2019-05-09

Plain-language summary

This study aims to compare the effectivity and efficiency of Modified Tarsorrhaphy (MT) technique and Gold Weight Implant (GWI) technique as a surgical treatment of paralytic lagophthalmos in leprosy patients. The hypothesis is that MT technique is more effective and more efficient than GWI technique. This study used PROBE (Prospective Randomized Open-label Blinded-Endpoint) clinical trial. Samples consisted of 14 eyes in MT group and 13 eyes in GWI group as the control group. This study was conducted in 3 hospitals in Indonesia and the patients were observed in 1 year period.

Who can participate

Age range

18 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: * paucibacillary (PB) or multibacillary (MB) type leprosy patient with unilateral/bilateral lagophthalmos who had not undergone eyelid reconstruction * patient aged 18 years old or older who could be performed surgery with local anesthesia Exclusion Criteria: * patient with acute leprosy reaction (\<6 months) and in steroid medication * patient with eyelid laxity \>8 mm

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

Lagophthalmos distance without pressure

Timeframe: Pre-operative

Lagophthalmos distance without pressure

Timeframe: 1 day post-operative

Lagophthalmos distance without pressure

Timeframe: 7 day post-operative

Lagophthalmos distance without pressure

Timeframe: 1 month post-operative

Lagophthalmos distance without pressure

Timeframe: 3 months post-operative

Lagophthalmos distance without pressure

Timeframe: 1 year post-operative

Lagophthalmos distance with gentle pressure

Timeframe: Pre-operative

Lagophthalmos distance with gentle pressure

Trial details

NCT IDNCT04944498

SponsorYunia Irawati

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-02-09

View on ClinicalTrials.gov More Paralytic Lagophthalmos trials

Plain-language summary

Who can participate

Age range

18 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.

What they're measuring

Lagophthalmos distance without pressure

Timeframe: Pre-operative

Lagophthalmos distance without pressure

Timeframe: 1 day post-operative

Lagophthalmos distance without pressure

Timeframe: 7 day post-operative

Lagophthalmos distance without pressure

Timeframe: 1 month post-operative

Lagophthalmos distance without pressure

Timeframe: 3 months post-operative

Lagophthalmos distance without pressure

Timeframe: 1 year post-operative

Lagophthalmos distance with gentle pressure

Timeframe: Pre-operative

Lagophthalmos distance with gentle pressure