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CompletedNCT04944498Updated Jun 29, 2021

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

An interventional study of Modified Tarsorrhaphy and Gold Weight Implant in Paralytic Lagophthalmos and Leprosy--Patients, sponsored by Yunia Irawati. Completed at 3 sites in Indonesia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-29.

Sponsored by Yunia Irawati · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years after the study started (first participant enrolled May 2019, registered Jun 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
19
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Paralytic Lagophthalmos
  • Leprosy--Patients

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Keywords

  • Hansen Disease
  • Leprosy
  • Paralytic lagophthalmos
  • Surgical intervention
03

In context

Leprosy

52 studies on the registry are indexed under Leprosy; 13 are open to participants now.

This study's enrollment of 19 is below the median of 70 across 41 interventional studies indexed under Leprosy.

Browse Leprosy studies →

Lead sponsor

This is the only study on the registry with Yunia Irawati as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • patient with acute leprosy reaction (\<6 months) and in medication
  • patient with eyelid laxity >8 mm
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
19 participants (actual)

Study arms

  • Experimental
    Intervention Group

    Patients who received surgery with modified tarsorrhaphy technique

    Procedure: Modified Tarsorrhaphy

  • Active comparator
    Control group

    Patients who received surgery with gold weight implant technique

    Procedure: Gold Weight Implant

Interventions

  • ProcedureModified Tarsorrhaphy

    A combination of levator recess, lateral tarsorrhaphy of 10 mm, and lateral canthopexy/lateral tarsal strip

  • ProcedureGold Weight Implant

    Installation of 1,5 gram gold weight implant above tarsal plate and underneath levator recess

06

What researchers measure

Primary outcomes

  1. Lagophthalmos distance without pressure

    Eyelid margin distance in central, nasal, and temporal area measured in millimeters

    Time frame: Pre-operative

  2. Lagophthalmos distance without pressure

    Eyelid margin distance in central, nasal, and temporal area measured in millimeters

    Time frame: 1 day post-operative

  3. Lagophthalmos distance without pressure

    Eyelid margin distance in central, nasal, and temporal area measured in millimeters

    Time frame: 7 day post-operative

  4. Lagophthalmos distance without pressure

    Eyelid margin distance in central, nasal, and temporal area measured in millimeters

    Time frame: 1 month post-operative

  5. Lagophthalmos distance without pressure

    Eyelid margin distance in central, nasal, and temporal area measured in millimeters

    Time frame: 3 months post-operative

  6. Lagophthalmos distance without pressure

    Eyelid margin distance in central, nasal, and temporal area measured in millimeters

    Time frame: 1 year post-operative

  7. Lagophthalmos distance with gentle pressure

    Eyelid margin distance in central, nasal, and temporal area measured in millimeters after applying minimal pressure on upper eyelid

    Time frame: Pre-operative

  8. Lagophthalmos distance with gentle pressure

    Eyelid margin distance in central, nasal, and temporal area measured in millimeters after applying minimal pressure on upper eyelid

    Time frame: 1 day post-operative

  9. Lagophthalmos distance with gentle pressure

    Eyelid margin distance in central, nasal, and temporal area measured in millimeters after applying minimal pressure on upper eyelid

    Time frame: 7 day post-operative

  10. Lagophthalmos distance with gentle pressure

    Eyelid margin distance in central, nasal, and temporal area measured in millimeters after applying minimal pressure on upper eyelid

    Time frame: 1 month post-operative

  11. Lagophthalmos distance with gentle pressure

    Eyelid margin distance in central, nasal, and temporal area measured in millimeters after applying minimal pressure on upper eyelid

    Time frame: 3 months post-operative

  12. Lagophthalmos distance with gentle pressure

    Eyelid margin distance in central, nasal, and temporal area measured in millimeters after applying minimal pressure on upper eyelid

    Time frame: 1 year post-operative

  13. OSDI (Ocular Surface Disease Index)

    Questionnaire assessing subjective dry eyes symptoms

    Time frame: Pre-operative

  14. OSDI (Ocular Surface Disease Index)

    Questionnaire assessing subjective dry eyes symptoms

    Time frame: 1 day post-operative

  15. OSDI (Ocular Surface Disease Index)

    Questionnaire assessing subjective dry eyes symptoms

    Time frame: 7 day post-operative

  16. OSDI (Ocular Surface Disease Index)

    Questionnaire assessing subjective dry eyes symptoms

    Time frame: 1 month post-operative

  17. OSDI (Ocular Surface Disease Index)

    Questionnaire assessing subjective dry eyes symptoms

    Time frame: 3 month post-operative

  18. OSDI (Ocular Surface Disease Index)

    Questionnaire assessing subjective dry eyes symptoms

    Time frame: 1 year post-operative

  19. TBUT (Tear Break-Up Time)

    Examination of tear break up time with fluorescein dye assessed with cobalt blue light from slit lamp

    Time frame: Pre-operative

  20. TBUT (Tear Break-Up Time)

    Examination of tear break up time with fluorescein dye assessed with cobalt blue light from slit lamp

    Time frame: 1 day post-operative

  21. TBUT (Tear Break-Up Time)

    Examination of tear break up time with fluorescein dye assessed with cobalt blue light from slit lamp

    Time frame: 7 day post-operative

  22. TBUT (Tear Break-Up Time)

    Examination of tear break up time with fluorescein dye assessed with cobalt blue light from slit lamp

    Time frame: 1 month post-operative

  23. TBUT (Tear Break-Up Time)

    Examination of tear break up time with fluorescein dye assessed with cobalt blue light from slit lamp

    Time frame: 3 months post-operative

  24. Schirmer test without anesthesia

    Tear film excretion examined using Whatman filter paper without anesthesia

    Time frame: Pre-operative

  25. Schirmer test without anesthesia

    Tear film excretion examined using Whatman filter paper without anesthesia

    Time frame: 1 day post-operative

  26. Schirmer test without anesthesia

    Tear film excretion examined using Whatman filter paper without anesthesia

    Time frame: 7 day post-operative

  27. Schirmer test without anesthesia

    Tear film excretion examined using Whatman filter paper without anesthesia

    Time frame: 1 month post-operative

  28. Schirmer test without anesthesia

    Tear film excretion examined using Whatman filter paper without anesthesia

    Time frame: 3 months post-operative

  29. Schirmer test without anesthesia

    Tear film excretion examined using Whatman filter paper without anesthesia

    Time frame: 1 year post-operative

  30. Schirmer test with anesthesia

    Tear film excretion examined using Whatman filter paper with anesthesia prior to examination

    Time frame: Pre-operative

  31. Schirmer test with anesthesia

    Tear film excretion examined using Whatman filter paper with anesthesia prior to examination

    Time frame: 1 day post-operative

  32. Schirmer test with anesthesia

    Tear film excretion examined using Whatman filter paper with anesthesia prior to examination

    Time frame: 7 day post-operative

  33. Schirmer test with anesthesia

    Tear film excretion examined using Whatman filter paper with anesthesia prior to examination

    Time frame: 1 month post-operative

  34. Schirmer test with anesthesia

    Tear film excretion examined using Whatman filter paper with anesthesia prior to examination

    Time frame: 3 months post-operative

  35. Schirmer test with anesthesia

    Tear film excretion examined using Whatman filter paper with anesthesia prior to examination

    Time frame: 1 year post-operative

  36. Epitheliopathy

    Epitheliopathy occurence, assessed with fluorescent dye and observed with cobalt blue light filter of slit lamp

    Time frame: Pre-operative

  37. Epitheliopathy

    Epitheliopathy occurence, assessed with fluorescent dye and observed with cobalt blue light filter of slit lamp

    Time frame: 1 day post-operative

  38. Epitheliopathy

    Epitheliopathy occurence, assessed with fluorescent dye and observed with cobalt blue light filter of slit lamp

    Time frame: 7 day post-operative

  39. Epitheliopathy

    Epitheliopathy occurence, assessed with fluorescent dye and observed with cobalt blue light filter of slit lamp

    Time frame: 1 month post-operative

  40. Epitheliopathy

    Epitheliopathy occurence, assessed with fluorescent dye and observed with cobalt blue light filter of slit lamp

    Time frame: 3 months post-operative

  41. Corneal exposure

    Exposed distance of cornea when the eye was closed

    Time frame: Pre-operative

  42. Corneal exposure

    Exposed distance of cornea when the eye was closed

    Time frame: 1 day post-operative

  43. Corneal exposure

    Exposed distance of cornea when the eye was closed

    Time frame: 7 day post-operative

  44. Corneal exposure

    Exposed distance of cornea when the eye was closed

    Time frame: 1 month post-operative

  45. Corneal exposure

    Exposed distance of cornea when the eye was closed

    Time frame: 3 months post-operative

  46. Corneal sensibility

    Sensibility measured in millimeters by using Luneau Cohcet-Bonnet Aesthesiometer

    Time frame: Pre-operative

  47. Corneal sensibility

    Sensibility measured in millimeters by using Luneau Cohcet-Bonnet Aesthesiometer

    Time frame: 1 day post-operative

  48. Corneal sensibility

    Sensibility measured in millimeters by using Luneau Cohcet-Bonnet Aesthesiometer

    Time frame: 7 day post-operative

  49. Corneal sensibility

    Sensibility measured in millimeters by using Luneau Cohcet-Bonnet Aesthesiometer

    Time frame: 1 month post-operative

  50. Corneal sensibility

    Sensibility measured in millimeters by using Luneau Cohcet-Bonnet Aesthesiometer

    Time frame: 3 months post-operative

  51. Complication

    Complication during surgery and after surgery

    Time frame: intraoperative

  52. Complication

    Complication during surgery and after surgery

    Time frame: 1 day post-operative

  53. Complication

    Complication during surgery and after surgery

    Time frame: 7 day post-operative

  54. Complication

    Complication during surgery and after surgery

    Time frame: 1 month post-operative

  55. Complication

    Complication during surgery and after surgery

    Time frame: 3 months post-operative

  56. Complication

    Complication during surgery and after surgery

    Time frame: 1 year post-operative

  57. Duration

    Duration of surgery

    Time frame: Intraoperative

  58. Cost

    Cost of surgery

    Time frame: 1 year post-operative

07

Study locations

3 sites
  • dr. Cipto Mangunkusumo Kirana Eye Hospital
    Jakarta Pusat, DKI Jakarta 10320, Indonesia
  • Jakarta Eye Center Hospitals and Clinics
    Jakarta, DKI Jakarta 10310, Indonesia
  • dr. Tadjuddin Chalid General Hospital
    Makassar, South Sulawesi 90241, Indonesia
08

References and documents

Publications

  • Pereira MV, Gloria AL. Lagophthalmos. Semin Ophthalmol. 2010 May;25(3):72-8. doi: 10.3109/08820538.2010.488578. PubMed 20590416 ↗
  • El Toukhy E. Gold weight implants in the management of lagophthalmos in leprosy patients. Lepr Rev. 2010 Mar;81(1):79-81. PubMed 20496572 ↗
  • Daniel E, Koshy S, Joseph GA, Rao PS. Ocular complications in incident relapsed borderline lepromatous and lepromatous leprosy patients in south India. Indian J Ophthalmol. 2003 Jun;51(2):155-9. PubMed 12831146 ↗
  • Nemet AY. Augmentation of lateral tarsorrhaphy in lagophthalmos. Orbit. 2014 Aug;33(4):289-91. doi: 10.3109/01676830.2014.894537. Epub 2014 Apr 30. PubMed 24786615 ↗
  • Aggarwal E, Naik MN, Honavar SG. Effectiveness of the gold weight trial procedure in predicting the ideal weight for lid loading in facial palsy: a prospective study. Am J Ophthalmol. 2007 Jun;143(6):1009-1012. doi: 10.1016/j.ajo.2007.03.026. Epub 2007 Apr 20. PubMed 17449001 ↗
  • Hontanilla B. Weight measurement of upper eyelid gold implants for lagophthalmos in facial paralysis. Plast Reconstr Surg. 2001 Nov;108(6):1539-43. doi: 10.1097/00006534-200111000-00016. PubMed 11711925 ↗
  • Lamba PA, Srinivasan R, Rohatgi J. Surgical management in ocular leprosy. Indian J Ophthalmol. 1987 May-Jun;35(3):153-7. No abstract available. PubMed 3507412 ↗
  • Koshy S, Daniel E, Kurian N, Yovan P. Pathogenesis of dry eye in leprosy and tear functions. Int J Lepr Other Mycobact Dis. 2001 Sep;69(3):215-8. PubMed 11875765 ↗
  • Li W, Yeh TN, Leung T, Yuen T, Lerma M, Lin MC. The Relationship of Lid Wiper Epitheliopathy to Ocular Surface Signs and Symptoms. Invest Ophthalmol Vis Sci. 2018 Apr 1;59(5):1878-1887. doi: 10.1167/iovs.17-23639. PubMed 29677348 ↗
  • Harrisberg BP, Singh RP, Croxson GR, Taylor RF, McCluskey PJ. Long-term outcome of gold eyelid weights in patients with facial nerve palsy. Otol Neurotol. 2001 May;22(3):397-400. doi: 10.1097/00129492-200105000-00022. PubMed 11347647 ↗
  • Hieselaar LC, Hogeweg M, de Vries CL. Corneal sensitivity in patients with leprosy and in controls. Br J Ophthalmol. 1995 Nov;79(11):993-5. doi: 10.1136/bjo.79.11.993. PubMed 8534670 ↗
  • Karacorlu MA, Cakiner T, Saylan T. Corneal sensitivity and correlations between decreased sensitivity and anterior segment pathology in ocular leprosy. Br J Ophthalmol. 1991 Feb;75(2):117-9. doi: 10.1136/bjo.75.2.117. PubMed 1995039 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2019 to primary completion in Feb 2020, 9 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 4, 2021
First posted
Jun 29, 2021
StartActual
May 9, 2019
Primary completionActual
Feb 9, 2020
CompletionActual
Apr 4, 2021
Last update
Jun 29, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 29, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04944498
Lead sponsor
Yunia Irawati
Responsible party
Yunia Irawati (Principal Investigator, Gadjah Mada University) — Sponsor-investigator
First posted
Jun 29, 2021
Start date
May 9, 2019
Primary completion
Feb 9, 2020
Completion
Apr 4, 2021
Last update
Jun 29, 2021

Study contacts

Yunia Irawati, Ophthalmologist Consultant
principal investigator · Indonesia University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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