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

Paralytic Lagophthalmos Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04944498
• Other study ID #: KE/FK/0525/EC/2019
• Status: Completed
• Phase: N/A
• Start date: May 9, 2019
• Est. completion date: April 4, 2021

Study information

• Verified date: June 2021
• Source: Gadjah Mada University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: April 4, 2021
• Est. primary completion date: February 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leprosy
• Paralytic Lagophthalmos

Intervention

Procedure:
• Modified Tarsorrhaphy
A combination of levator recess, lateral tarsorrhaphy of 10 mm, and lateral canthopexy/lateral tarsal strip
• Gold Weight Implant
Installation of 1,5 gram gold weight implant above tarsal plate and underneath levator recess

Locations

Country	Name	City	State
Indonesia	Jakarta Eye Center Hospitals and Clinics	Jakarta	DKI Jakarta
Indonesia	dr. Cipto Mangunkusumo Kirana Eye Hospital	Jakarta Pusat	DKI Jakarta
Indonesia	dr. Tadjuddin Chalid General Hospital	Makassar	South Sulawesi

Sponsors (1)

Lead Sponsor	Collaborator
Yunia Irawati

Country where clinical trial is conducted

Indonesia, 

References & Publications (12)

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. Epub 2007 Apr 20. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

Hontanilla B. Weight measurement of upper eyelid gold implants for lagophthalmos in facial paralysis. Plast Reconstr Surg. 2001 Nov;108(6):1539-43. — View Citation

Karaçorlu 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. — View Citation

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. — View Citation

Lamba PA, Srinivasan R, Rohatgi J. Surgical management in ocular leprosy. Indian J Ophthalmol. 1987 May-Jun;35(3):153-7. — View Citation

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. — View Citation

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. — View Citation

Pereira MV, Glória AL. Lagophthalmos. Semin Ophthalmol. 2010 May;25(3):72-8. doi: 10.3109/08820538.2010.488578. Review. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lagophthalmos distance without pressure	Eyelid margin distance in central, nasal, and temporal area measured in millimeters	Pre-operative
Primary	Lagophthalmos distance without pressure	Eyelid margin distance in central, nasal, and temporal area measured in millimeters	1 day post-operative
Primary	Lagophthalmos distance without pressure	Eyelid margin distance in central, nasal, and temporal area measured in millimeters	7 day post-operative
Primary	Lagophthalmos distance without pressure	Eyelid margin distance in central, nasal, and temporal area measured in millimeters	1 month post-operative
Primary	Lagophthalmos distance without pressure	Eyelid margin distance in central, nasal, and temporal area measured in millimeters	3 months post-operative
Primary	Lagophthalmos distance without pressure	Eyelid margin distance in central, nasal, and temporal area measured in millimeters	1 year post-operative
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	OSDI (Ocular Surface Disease Index)	Questionnaire assessing subjective dry eyes symptoms	Pre-operative
Primary	OSDI (Ocular Surface Disease Index)	Questionnaire assessing subjective dry eyes symptoms	1 day post-operative
Primary	OSDI (Ocular Surface Disease Index)	Questionnaire assessing subjective dry eyes symptoms	7 day post-operative
Primary	OSDI (Ocular Surface Disease Index)	Questionnaire assessing subjective dry eyes symptoms	1 month post-operative
Primary	OSDI (Ocular Surface Disease Index)	Questionnaire assessing subjective dry eyes symptoms	3 month post-operative
Primary	OSDI (Ocular Surface Disease Index)	Questionnaire assessing subjective dry eyes symptoms	1 year post-operative
Primary	TBUT (Tear Break-Up Time)	Examination of tear break up time with fluorescein dye assessed with cobalt blue light from slit lamp	Pre-operative
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Schirmer test without anesthesia	Tear film excretion examined using Whatman filter paper without anesthesia	Pre-operative
Primary	Schirmer test without anesthesia	Tear film excretion examined using Whatman filter paper without anesthesia	1 day post-operative
Primary	Schirmer test without anesthesia	Tear film excretion examined using Whatman filter paper without anesthesia	7 day post-operative
Primary	Schirmer test without anesthesia	Tear film excretion examined using Whatman filter paper without anesthesia	1 month post-operative
Primary	Schirmer test without anesthesia	Tear film excretion examined using Whatman filter paper without anesthesia	3 months post-operative
Primary	Schirmer test without anesthesia	Tear film excretion examined using Whatman filter paper without anesthesia	1 year post-operative
Primary	Schirmer test with anesthesia	Tear film excretion examined using Whatman filter paper with anesthesia prior to examination	Pre-operative
Primary	Schirmer test with anesthesia	Tear film excretion examined using Whatman filter paper with anesthesia prior to examination	1 day post-operative
Primary	Schirmer test with anesthesia	Tear film excretion examined using Whatman filter paper with anesthesia prior to examination	7 day post-operative
Primary	Schirmer test with anesthesia	Tear film excretion examined using Whatman filter paper with anesthesia prior to examination	1 month post-operative
Primary	Schirmer test with anesthesia	Tear film excretion examined using Whatman filter paper with anesthesia prior to examination	3 months post-operative
Primary	Schirmer test with anesthesia	Tear film excretion examined using Whatman filter paper with anesthesia prior to examination	1 year post-operative
Primary	Epitheliopathy	Epitheliopathy occurence, assessed with fluorescent dye and observed with cobalt blue light filter of slit lamp	Pre-operative
Primary	Epitheliopathy	Epitheliopathy occurence, assessed with fluorescent dye and observed with cobalt blue light filter of slit lamp	1 day post-operative
Primary	Epitheliopathy	Epitheliopathy occurence, assessed with fluorescent dye and observed with cobalt blue light filter of slit lamp	7 day post-operative
Primary	Epitheliopathy	Epitheliopathy occurence, assessed with fluorescent dye and observed with cobalt blue light filter of slit lamp	1 month post-operative
Primary	Epitheliopathy	Epitheliopathy occurence, assessed with fluorescent dye and observed with cobalt blue light filter of slit lamp	3 months post-operative
Primary	Corneal exposure	Exposed distance of cornea when the eye was closed	Pre-operative
Primary	Corneal exposure	Exposed distance of cornea when the eye was closed	1 day post-operative
Primary	Corneal exposure	Exposed distance of cornea when the eye was closed	7 day post-operative
Primary	Corneal exposure	Exposed distance of cornea when the eye was closed	1 month post-operative
Primary	Corneal exposure	Exposed distance of cornea when the eye was closed	3 months post-operative
Primary	Corneal sensibility	Sensibility measured in millimeters by using Luneau Cohcet-Bonnet Aesthesiometer	Pre-operative
Primary	Corneal sensibility	Sensibility measured in millimeters by using Luneau Cohcet-Bonnet Aesthesiometer	1 day post-operative
Primary	Corneal sensibility	Sensibility measured in millimeters by using Luneau Cohcet-Bonnet Aesthesiometer	7 day post-operative
Primary	Corneal sensibility	Sensibility measured in millimeters by using Luneau Cohcet-Bonnet Aesthesiometer	1 month post-operative
Primary	Corneal sensibility	Sensibility measured in millimeters by using Luneau Cohcet-Bonnet Aesthesiometer	3 months post-operative
Primary	Complication	Complication during surgery and after surgery	intraoperative
Primary	Complication	Complication during surgery and after surgery	1 day post-operative
Primary	Complication	Complication during surgery and after surgery	7 day post-operative
Primary	Complication	Complication during surgery and after surgery	1 month post-operative
Primary	Complication	Complication during surgery and after surgery	3 months post-operative
Primary	Complication	Complication during surgery and after surgery	1 year post-operative
Primary	Duration	Duration of surgery	Intraoperative
Primary	Cost	Cost of surgery	1 year post-operative