NCT04944498

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 9, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 9, 2020

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2021

Completed
25 days until next milestone

First Posted

Study publicly available on registry

June 29, 2021

Completed
Last Updated

June 29, 2021

Status Verified

June 1, 2021

Enrollment Period

9 months

First QC Date

June 4, 2021

Last Update Submit

June 27, 2021

Conditions

Paralytic LagophthalmosLeprosy--Patients

Keywords

Hansen DiseaseLeprosyParalytic lagophthalmosSurgical intervention

Outcome Measures

Primary Outcomes (58)

  • Lagophthalmos distance without pressure

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

    Pre-operative

  • Lagophthalmos distance without pressure

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

    1 day post-operative

  • Lagophthalmos distance without pressure

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

    7 day post-operative

  • Lagophthalmos distance without pressure

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

    1 month post-operative

  • Lagophthalmos distance without pressure

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

    3 months post-operative

  • Lagophthalmos distance without pressure

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

    1 year post-operative

  • Lagophthalmos distance with gentle pressure

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

    Pre-operative

  • Lagophthalmos distance with gentle pressure

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

    1 day post-operative

  • Lagophthalmos distance with gentle pressure

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

    7 day post-operative

  • Lagophthalmos distance with gentle pressure

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

    1 month post-operative

  • Lagophthalmos distance with gentle pressure

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

    3 months post-operative

  • Lagophthalmos distance with gentle pressure

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

    1 year post-operative

  • OSDI (Ocular Surface Disease Index)

    Questionnaire assessing subjective dry eyes symptoms

    Pre-operative

  • OSDI (Ocular Surface Disease Index)

    Questionnaire assessing subjective dry eyes symptoms

    1 day post-operative

  • OSDI (Ocular Surface Disease Index)

    Questionnaire assessing subjective dry eyes symptoms

    7 day post-operative

  • OSDI (Ocular Surface Disease Index)

    Questionnaire assessing subjective dry eyes symptoms

    1 month post-operative

  • OSDI (Ocular Surface Disease Index)

    Questionnaire assessing subjective dry eyes symptoms

    3 month post-operative

  • OSDI (Ocular Surface Disease Index)

    Questionnaire assessing subjective dry eyes symptoms

    1 year post-operative

  • TBUT (Tear Break-Up Time)

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

    Pre-operative

  • TBUT (Tear Break-Up Time)

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

    1 day post-operative

  • TBUT (Tear Break-Up Time)

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

    7 day post-operative

  • TBUT (Tear Break-Up Time)

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

    1 month post-operative

  • TBUT (Tear Break-Up Time)

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

    3 months post-operative

  • Schirmer test without anesthesia

    Tear film excretion examined using Whatman filter paper without anesthesia

    Pre-operative

  • Schirmer test without anesthesia

    Tear film excretion examined using Whatman filter paper without anesthesia

    1 day post-operative

  • Schirmer test without anesthesia

    Tear film excretion examined using Whatman filter paper without anesthesia

    7 day post-operative

  • Schirmer test without anesthesia

    Tear film excretion examined using Whatman filter paper without anesthesia

    1 month post-operative

  • Schirmer test without anesthesia

    Tear film excretion examined using Whatman filter paper without anesthesia

    3 months post-operative

  • Schirmer test without anesthesia

    Tear film excretion examined using Whatman filter paper without anesthesia

    1 year post-operative

  • Schirmer test with anesthesia

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

    Pre-operative

  • Schirmer test with anesthesia

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

    1 day post-operative

  • Schirmer test with anesthesia

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

    7 day post-operative

  • Schirmer test with anesthesia

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

    1 month post-operative

  • Schirmer test with anesthesia

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

    3 months post-operative

  • Schirmer test with anesthesia

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

    1 year post-operative

  • Epitheliopathy

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

    Pre-operative

  • Epitheliopathy

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

    1 day post-operative

  • Epitheliopathy

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

    7 day post-operative

  • Epitheliopathy

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

    1 month post-operative

  • Epitheliopathy

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

    3 months post-operative

  • Corneal exposure

    Exposed distance of cornea when the eye was closed

    Pre-operative

  • Corneal exposure

    Exposed distance of cornea when the eye was closed

    1 day post-operative

  • Corneal exposure

    Exposed distance of cornea when the eye was closed

    7 day post-operative

  • Corneal exposure

    Exposed distance of cornea when the eye was closed

    1 month post-operative

  • Corneal exposure

    Exposed distance of cornea when the eye was closed

    3 months post-operative

  • Corneal sensibility

    Sensibility measured in millimeters by using Luneau Cohcet-Bonnet Aesthesiometer

    Pre-operative

  • Corneal sensibility

    Sensibility measured in millimeters by using Luneau Cohcet-Bonnet Aesthesiometer

    1 day post-operative

  • Corneal sensibility

    Sensibility measured in millimeters by using Luneau Cohcet-Bonnet Aesthesiometer

    7 day post-operative

  • Corneal sensibility

    Sensibility measured in millimeters by using Luneau Cohcet-Bonnet Aesthesiometer

    1 month post-operative

  • Corneal sensibility

    Sensibility measured in millimeters by using Luneau Cohcet-Bonnet Aesthesiometer

    3 months post-operative

  • Complication

    Complication during surgery and after surgery

    intraoperative

  • Complication

    Complication during surgery and after surgery

    1 day post-operative

  • Complication

    Complication during surgery and after surgery

    7 day post-operative

  • Complication

    Complication during surgery and after surgery

    1 month post-operative

  • Complication

    Complication during surgery and after surgery

    3 months post-operative

  • Complication

    Complication during surgery and after surgery

    1 year post-operative

  • Duration

    Duration of surgery

    Intraoperative

  • Cost

    Cost of surgery

    1 year post-operative

Study Arms (2)

Intervention Group

EXPERIMENTAL

Patients who received surgery with modified tarsorrhaphy technique

Procedure: Modified Tarsorrhaphy

Control group

ACTIVE COMPARATOR

Patients who received surgery with gold weight implant technique

Procedure: Gold Weight Implant

Interventions

Modified TarsorrhaphyPROCEDURE

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

Intervention Group
Gold Weight ImplantPROCEDURE

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

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • patient with acute leprosy reaction (\<6 months) and in steroid medication
  • patient with eyelid laxity \>8 mm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Jakarta Eye Center Hospitals and Clinics

Jakarta, DKI Jakarta, 10310, Indonesia

Location

dr. Cipto Mangunkusumo Kirana Eye Hospital

Jakarta Pusat, DKI Jakarta, 10320, Indonesia

Location

dr. Tadjuddin Chalid General Hospital

Makassar, South Sulawesi, 90241, Indonesia

Location

Related Publications (12)

  • Pereira MV, Gloria AL. Lagophthalmos. Semin Ophthalmol. 2010 May;25(3):72-8. doi: 10.3109/08820538.2010.488578.

    PMID: 20590416BACKGROUND

  • El Toukhy E. Gold weight implants in the management of lagophthalmos in leprosy patients. Lepr Rev. 2010 Mar;81(1):79-81.

    PMID: 20496572BACKGROUND

  • 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.

    PMID: 12831146BACKGROUND

  • 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.

    PMID: 24786615BACKGROUND

  • 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.

    PMID: 17449001BACKGROUND

  • 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.

    PMID: 11711925BACKGROUND

  • Lamba PA, Srinivasan R, Rohatgi J. Surgical management in ocular leprosy. Indian J Ophthalmol. 1987 May-Jun;35(3):153-7. No abstract available.

    PMID: 3507412BACKGROUND

  • 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.

    PMID: 11875765BACKGROUND

  • 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.

    PMID: 29677348BACKGROUND

  • 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.

    PMID: 11347647BACKGROUND

  • 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.

    PMID: 8534670BACKGROUND

  • 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.

    PMID: 1995039BACKGROUND

MeSH Terms

Conditions

LagophthalmosLeprosy

Condition Hierarchy (Ancestors)

Eye ManifestationsEye DiseasesEyelid DiseasesMycobacterium Infections, NontuberculousMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Yunia Irawati, Ophthalmologist Consultant

    Indonesia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Treatment received by patients was randomized by research team members. The investigator as the oculoplastic surgeon (YI) acknowledged the treatment assigned to each patient based on randomization. Outcomes were measured by other oculoplastic surgeons with equal clinical experiences.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 4, 2021

First Posted

June 29, 2021

Study Start

May 9, 2019

Primary Completion

February 9, 2020

Study Completion

April 4, 2021

Last Updated

June 29, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

ID(3)