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

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

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.

Study Overview

• Status: Completed
• Conditions: Paralytic Lagophthalmos; Leprosy--Patients
• Intervention / Treatment: Procedure: Modified Tarsorrhaphy; Procedure: Gold Weight Implant

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; Patients who received surgery with modified tarsorrhaphy technique	Procedure: Modified Tarsorrhaphy; A combination of levator recess, lateral tarsorrhaphy of 10 mm, and lateral canthopexy/lateral tarsal strip
Active Comparator: Control group; Patients who received surgery with gold weight implant technique	Procedure: Gold Weight Implant; Installation of 1,5 gram gold weight implant above tarsal plate and underneath levator recess

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Yunia Irawati
• Investigators: Principal Investigator: Yunia Irawati, Ophthalmologist Consultant, Indonesia University

Publications and helpful links

General Publications

• Pereira MV, Gloria AL. Lagophthalmos. Semin Ophthalmol. 2010 May;25(3):72-8. doi: 10.3109/08820538.2010.488578.
• El Toukhy E. Gold weight implants in the management of lagophthalmos in leprosy patients. Lepr Rev. 2010 Mar;81(1):79-81.
• 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.
• 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.
• 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.
• 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.
• Lamba PA, Srinivasan R, Rohatgi J. Surgical management in ocular leprosy. Indian J Ophthalmol. 1987 May-Jun;35(3):153-7. No abstract available.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2019
• Primary Completion (Actual): February 9, 2020
• Study Completion (Actual): April 4, 2021

Study Registration Dates

• First Submitted: June 4, 2021
• First Submitted That Met QC Criteria: June 27, 2021
• First Posted (Actual): June 29, 2021

Study Record Updates

• Last Update Posted (Actual): June 29, 2021
• Last Update Submitted That Met QC Criteria: June 27, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Leprosy; Hansen Disease; Paralytic lagophthalmos; Surgical intervention
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Mycobacterium Infections, Nontuberculous; Leprosy
• Other Study ID Numbers: KE/FK/0525/EC/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No