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Completed

NCT Number: NCT04944498

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

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.

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Key information

Conditions

Paralytic Lagophthalmos Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Eye Diseases Eye Manifestations Eyelid Diseases Gram-Positive Bacterial Infections Infections Lagophthalmos Leprosy Leprosy--Patients Mycobacterium Infections Mycobacterium Infections, Nontuberculous

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jakarta Eye Center Hospitals and Clinics, Jakarta, DKI Jakarta, Indonesia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Modified Tarsorrhaphy

Procedure

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

Gold Weight Implant

Procedure

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

Primary outcomes

  1. Lagophthalmos distance without pressure

    Time frame: Pre-operative

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

  2. Lagophthalmos distance without pressure

    Time frame: 1 day post-operative

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

  3. Lagophthalmos distance without pressure

    Time frame: 7 day post-operative

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

  4. Lagophthalmos distance without pressure

    Time frame: 1 month post-operative

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

  5. Lagophthalmos distance without pressure

    Time frame: 3 months post-operative

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

  6. Lagophthalmos distance without pressure

    Time frame: 1 year post-operative

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

  7. Lagophthalmos distance with gentle pressure

    Time frame: Pre-operative

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

  8. Lagophthalmos distance with gentle pressure

    Time frame: 1 day post-operative

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

  9. Lagophthalmos distance with gentle pressure

    Time frame: 7 day post-operative

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

  10. Lagophthalmos distance with gentle pressure

    Time frame: 1 month post-operative

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

  11. Lagophthalmos distance with gentle pressure

    Time frame: 3 months post-operative

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

  12. Lagophthalmos distance with gentle pressure

    Time frame: 1 year post-operative

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

  13. OSDI (Ocular Surface Disease Index)

    Time frame: Pre-operative

    Questionnaire assessing subjective dry eyes symptoms

  14. OSDI (Ocular Surface Disease Index)

    Time frame: 1 day post-operative

    Questionnaire assessing subjective dry eyes symptoms

  15. OSDI (Ocular Surface Disease Index)

    Time frame: 7 day post-operative

    Questionnaire assessing subjective dry eyes symptoms

  16. OSDI (Ocular Surface Disease Index)

    Time frame: 1 month post-operative

    Questionnaire assessing subjective dry eyes symptoms

  17. OSDI (Ocular Surface Disease Index)

    Time frame: 3 month post-operative

    Questionnaire assessing subjective dry eyes symptoms

  18. OSDI (Ocular Surface Disease Index)

    Time frame: 1 year post-operative

    Questionnaire assessing subjective dry eyes symptoms

  19. TBUT (Tear Break-Up Time)

    Time frame: Pre-operative

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

  20. TBUT (Tear Break-Up Time)

    Time frame: 1 day post-operative

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

  21. TBUT (Tear Break-Up Time)

    Time frame: 7 day post-operative

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

  22. TBUT (Tear Break-Up Time)

    Time frame: 1 month post-operative

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

  23. TBUT (Tear Break-Up Time)

    Time frame: 3 months post-operative

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

  24. Schirmer test without anesthesia

    Time frame: Pre-operative

    Tear film excretion examined using Whatman filter paper without anesthesia

  25. Schirmer test without anesthesia

    Time frame: 1 day post-operative

    Tear film excretion examined using Whatman filter paper without anesthesia

  26. Schirmer test without anesthesia

    Time frame: 7 day post-operative

    Tear film excretion examined using Whatman filter paper without anesthesia

  27. Schirmer test without anesthesia

    Time frame: 1 month post-operative

    Tear film excretion examined using Whatman filter paper without anesthesia

  28. Schirmer test without anesthesia

    Time frame: 3 months post-operative

    Tear film excretion examined using Whatman filter paper without anesthesia

  29. Schirmer test without anesthesia

    Time frame: 1 year post-operative

    Tear film excretion examined using Whatman filter paper without anesthesia

  30. Schirmer test with anesthesia

    Time frame: Pre-operative

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

  31. Schirmer test with anesthesia

    Time frame: 1 day post-operative

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

  32. Schirmer test with anesthesia

    Time frame: 7 day post-operative

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

  33. Schirmer test with anesthesia

    Time frame: 1 month post-operative

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

  34. Schirmer test with anesthesia

    Time frame: 3 months post-operative

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

  35. Schirmer test with anesthesia

    Time frame: 1 year post-operative

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

  36. Epitheliopathy

    Time frame: Pre-operative

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

  37. Epitheliopathy

    Time frame: 1 day post-operative

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

  38. Epitheliopathy

    Time frame: 7 day post-operative

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

  39. Epitheliopathy

    Time frame: 1 month post-operative

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

  40. Epitheliopathy

    Time frame: 3 months post-operative

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

  41. Corneal exposure

    Time frame: Pre-operative

    Exposed distance of cornea when the eye was closed

  42. Corneal exposure

    Time frame: 1 day post-operative

    Exposed distance of cornea when the eye was closed

  43. Corneal exposure

    Time frame: 7 day post-operative

    Exposed distance of cornea when the eye was closed

  44. Corneal exposure

    Time frame: 1 month post-operative

    Exposed distance of cornea when the eye was closed

  45. Corneal exposure

    Time frame: 3 months post-operative

    Exposed distance of cornea when the eye was closed

  46. Corneal sensibility

    Time frame: Pre-operative

    Sensibility measured in millimeters by using Luneau Cohcet-Bonnet Aesthesiometer

  47. Corneal sensibility

    Time frame: 1 day post-operative

    Sensibility measured in millimeters by using Luneau Cohcet-Bonnet Aesthesiometer

  48. Corneal sensibility

    Time frame: 7 day post-operative

    Sensibility measured in millimeters by using Luneau Cohcet-Bonnet Aesthesiometer

  49. Corneal sensibility

    Time frame: 1 month post-operative

    Sensibility measured in millimeters by using Luneau Cohcet-Bonnet Aesthesiometer

  50. Corneal sensibility

    Time frame: 3 months post-operative

    Sensibility measured in millimeters by using Luneau Cohcet-Bonnet Aesthesiometer

  51. Complication

    Time frame: intraoperative

    Complication during surgery and after surgery

  52. Complication

    Time frame: 1 day post-operative

    Complication during surgery and after surgery

  53. Complication

    Time frame: 7 day post-operative

    Complication during surgery and after surgery

  54. Complication

    Time frame: 1 month post-operative

    Complication during surgery and after surgery

  55. Complication

    Time frame: 3 months post-operative

    Complication during surgery and after surgery

  56. Complication

    Time frame: 1 year post-operative

    Complication during surgery and after surgery

  57. Duration

    Time frame: Intraoperative

    Duration of surgery

  58. Cost

    Time frame: 1 year post-operative

    Cost of surgery

Sponsors and collaborators

Lead sponsor

Yunia Irawati

Other

Registry information

Official study title

Modified Tarsorrhaphy vs Gold Weight Implant Technique for Paralytic Lagophthalmos Treatment in Leprosy Patients: a Randomized Clinical Trial

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Jun 29, 2021
Registry last updated
Jun 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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