Paralytic LagophthalmosNCT04944498
Modified Tarsorrhaphy vs Gold Weight Implant for Paralytic Lagophthalmos in Leprosy Patients
A study testing Modified Tarsorrhaphy and Gold Weight Implant in people with Paralytic Lagophthalmos and Leprosy--Patients, run by Yunia Irawati at 3 sites in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paralytic Lagophthalmos, Leprosy--Patients
- What is being tested?
- Modified Tarsorrhaphy and Gold Weight Implant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 3 sitesIndonesia
- Study dates
- 9 May 2019to 4 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- patient with acute leprosy reaction (<6 months) and in steroid medication
- patient with eyelid laxity >8 mm
Trial locations and contacts
3 sites in 1 country.
Indonesia3 sites
Jakarta Eye Center Hospitals and Clinics
Jakarta, DKI Jakarta, 10310
dr. Cipto Mangunkusumo Kirana Eye Hospital
Jakarta Pusat, DKI Jakarta, 10320
dr. Tadjuddin Chalid General Hospital
Makassar, South Sulawesi, 90241
About this study
Official title: 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.
- Conditions
- Paralytic Lagophthalmos, Leprosy--Patients
- Being tested
- Modified Tarsorrhaphy, Gold Weight Implant
- Keywords
- Hansen Disease, Leprosy, Paralytic lagophthalmos, Surgical intervention
- Medical subject headings
- Lagophthalmos, Leprosy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified TarsorrhaphyProcedure or surgery
A combination of levator recess, lateral tarsorrhaphy of 10 mm, and lateral canthopexy/lateral tarsal strip
Gold Weight ImplantProcedure or surgery
Installation of 1,5 gram gold weight implant above tarsal plate and underneath levator recess
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Patients who received surgery with modified tarsorrhaphy technique Receives: Procedure: Modified Tarsorrhaphy |
| Control group | Active comparator | Patients who received surgery with gold weight implant technique Receives: Procedure: Gold Weight Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lagophthalmos distance without pressure
Eyelid margin distance in central, nasal, and temporal area measured in millimeters
Measured: Pre-operative
Lagophthalmos distance without pressure
Eyelid margin distance in central, nasal, and temporal area measured in millimeters
Measured: 1 day post-operative
Lagophthalmos distance without pressure
Eyelid margin distance in central, nasal, and temporal area measured in millimeters
Measured: 7 day post-operative
Lagophthalmos distance without pressure
Eyelid margin distance in central, nasal, and temporal area measured in millimeters
Measured: 1 month post-operative
Lagophthalmos distance without pressure
Eyelid margin distance in central, nasal, and temporal area measured in millimeters
Measured: 3 months post-operative
Lagophthalmos distance without pressure
Eyelid margin distance in central, nasal, and temporal area measured in millimeters
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 1 year post-operative
OSDI (Ocular Surface Disease Index)
Questionnaire assessing subjective dry eyes symptoms
Measured: Pre-operative
OSDI (Ocular Surface Disease Index)
Questionnaire assessing subjective dry eyes symptoms
Measured: 1 day post-operative
OSDI (Ocular Surface Disease Index)
Questionnaire assessing subjective dry eyes symptoms
Measured: 7 day post-operative
OSDI (Ocular Surface Disease Index)
Questionnaire assessing subjective dry eyes symptoms
Measured: 1 month post-operative
OSDI (Ocular Surface Disease Index)
Questionnaire assessing subjective dry eyes symptoms
Measured: 3 month post-operative
OSDI (Ocular Surface Disease Index)
Questionnaire assessing subjective dry eyes symptoms
Measured: 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
Measured: Pre-operative
TBUT (Tear Break-Up Time)
Examination of tear break up time with fluorescein dye assessed with cobalt blue light from slit lamp
Measured: 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
Measured: 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
Measured: 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
Measured: 3 months post-operative
Schirmer test without anesthesia
Tear film excretion examined using Whatman filter paper without anesthesia
Measured: Pre-operative
Schirmer test without anesthesia
Tear film excretion examined using Whatman filter paper without anesthesia
Measured: 1 day post-operative
Schirmer test without anesthesia
Tear film excretion examined using Whatman filter paper without anesthesia
Measured: 7 day post-operative
Schirmer test without anesthesia
Tear film excretion examined using Whatman filter paper without anesthesia
Measured: 1 month post-operative
Schirmer test without anesthesia
Tear film excretion examined using Whatman filter paper without anesthesia
Measured: 3 months post-operative
Schirmer test without anesthesia
Tear film excretion examined using Whatman filter paper without anesthesia
Measured: 1 year post-operative
Schirmer test with anesthesia
Tear film excretion examined using Whatman filter paper with anesthesia prior to examination
Measured: Pre-operative
Schirmer test with anesthesia
Tear film excretion examined using Whatman filter paper with anesthesia prior to examination
Measured: 1 day post-operative
Schirmer test with anesthesia
Tear film excretion examined using Whatman filter paper with anesthesia prior to examination
Measured: 7 day post-operative
Schirmer test with anesthesia
Tear film excretion examined using Whatman filter paper with anesthesia prior to examination
Measured: 1 month post-operative
Schirmer test with anesthesia
Tear film excretion examined using Whatman filter paper with anesthesia prior to examination
Measured: 3 months post-operative
Schirmer test with anesthesia
Tear film excretion examined using Whatman filter paper with anesthesia prior to examination
Measured: 1 year post-operative
Epitheliopathy
Epitheliopathy occurence, assessed with fluorescent dye and observed with cobalt blue light filter of slit lamp
Measured: Pre-operative
Epitheliopathy
Epitheliopathy occurence, assessed with fluorescent dye and observed with cobalt blue light filter of slit lamp
Measured: 1 day post-operative
Epitheliopathy
Epitheliopathy occurence, assessed with fluorescent dye and observed with cobalt blue light filter of slit lamp
Measured: 7 day post-operative
Epitheliopathy
Epitheliopathy occurence, assessed with fluorescent dye and observed with cobalt blue light filter of slit lamp
Measured: 1 month post-operative
Epitheliopathy
Epitheliopathy occurence, assessed with fluorescent dye and observed with cobalt blue light filter of slit lamp
Measured: 3 months post-operative
Corneal exposure
Exposed distance of cornea when the eye was closed
Measured: Pre-operative
Corneal exposure
Exposed distance of cornea when the eye was closed
Measured: 1 day post-operative
Corneal exposure
Exposed distance of cornea when the eye was closed
Measured: 7 day post-operative
Corneal exposure
Exposed distance of cornea when the eye was closed
Measured: 1 month post-operative
Corneal exposure
Exposed distance of cornea when the eye was closed
Measured: 3 months post-operative
Corneal sensibility
Sensibility measured in millimeters by using Luneau Cohcet-Bonnet Aesthesiometer
Measured: Pre-operative
Corneal sensibility
Sensibility measured in millimeters by using Luneau Cohcet-Bonnet Aesthesiometer
Measured: 1 day post-operative
Corneal sensibility
Sensibility measured in millimeters by using Luneau Cohcet-Bonnet Aesthesiometer
Measured: 7 day post-operative
Corneal sensibility
Sensibility measured in millimeters by using Luneau Cohcet-Bonnet Aesthesiometer
Measured: 1 month post-operative
Corneal sensibility
Sensibility measured in millimeters by using Luneau Cohcet-Bonnet Aesthesiometer
Measured: 3 months post-operative
Complication
Complication during surgery and after surgery
Measured: intraoperative
Complication
Complication during surgery and after surgery
Measured: 1 day post-operative
Complication
Complication during surgery and after surgery
Measured: 7 day post-operative
Complication
Complication during surgery and after surgery
Measured: 1 month post-operative
Complication
Complication during surgery and after surgery
Measured: 3 months post-operative
Complication
Complication during surgery and after surgery
Measured: 1 year post-operative
Duration
Duration of surgery
Measured: Intraoperative
Cost
Cost of surgery
Measured: 1 year post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start9 May 2019
- Primary completion9 Feb 2020
- Study completion4 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Paralytic LagophthalmosStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yunia Irawati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yunia Irawati, Gadjah Mada University
- Investigators
- Yunia Irawati, Ophthalmologist Consultant, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04944498
- Sponsor's protocol ID
- KE/FK/0525/EC/2019
- Status last verified
- Jun 2021
- First submitted
- 4 Jun 2021
- Last updated
- 29 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pereira MV, Gloria AL. Lagophthalmos. Semin Ophthalmol. 2010 May;25(3):72-8. doi: 10.3109/08820538.2010.488578.
PubMed 20590416El Toukhy E. Gold weight implants in the management of lagophthalmos in leprosy patients. Lepr Rev. 2010 Mar;81(1):79-81.
PubMed 20496572Daniel 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 12831146Nemet 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 24786615Aggarwal 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 17449001Hontanilla 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 11711925Lamba PA, Srinivasan R, Rohatgi J. Surgical management in ocular leprosy. Indian J Ophthalmol. 1987 May-Jun;35(3):153-7. No abstract available.
PubMed 3507412Koshy 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 11875765Li 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 29677348Harrisberg 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 11347647Hieselaar 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 8534670Karacorlu 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Tarsorrhaphy vs Gold Weight Implant Technique for Paralytic Lagophthalmos Treatment in Leprosy Patients: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04944498
- Acronym / sponsor ID
- KE/FK/0525/EC/2019
- Conditions
- Paralytic Lagophthalmos, Leprosy--Patients
- Keywords
- Hansen Disease, Leprosy, Paralytic lagophthalmos, Surgical intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Yunia IrawatiUniversity, hospital or other
- Study start
- 9 May 2019 (actual)
- Primary completion
- 9 Feb 2020 (actual)
- Study completion
- 4 Apr 2021 (actual)
- First posted
- 29 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Procedure: Modified TarsorrhaphyPatients who received surgery with modified tarsorrhaphy technique |
| Control group | Active comparator | Procedure: Gold Weight ImplantPatients who received surgery with gold weight implant technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- patient with acute leprosy reaction (<6 months) and in steroid medication
- patient with eyelid laxity >8 mm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified TarsorrhaphyA combination of levator recess, lateral tarsorrhaphy of 10 mm, and lateral canthopexy/lateral tarsal strip | Procedure or surgery | Intervention Group |
| Gold Weight ImplantInstallation of 1,5 gram gold weight implant above tarsal plate and underneath levator recess | Procedure or surgery | Control group |
Primary outcome
Lagophthalmos distance without pressure
Time frame: Pre-operative
Eyelid margin distance in central, nasal, and temporal area measured in millimeters
Lagophthalmos distance without pressure
Time frame: 1 day post-operative
Eyelid margin distance in central, nasal, and temporal area measured in millimeters
Lagophthalmos distance without pressure
Time frame: 7 day post-operative
Eyelid margin distance in central, nasal, and temporal area measured in millimeters
Lagophthalmos distance without pressure
Time frame: 1 month post-operative
Eyelid margin distance in central, nasal, and temporal area measured in millimeters
Lagophthalmos distance without pressure
Time frame: 3 months post-operative
Eyelid margin distance in central, nasal, and temporal area measured in millimeters
Lagophthalmos distance without pressure
Time frame: 1 year post-operative
Eyelid margin distance in central, nasal, and temporal area measured in millimeters
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
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
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
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
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
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
OSDI (Ocular Surface Disease Index)
Time frame: Pre-operative
Questionnaire assessing subjective dry eyes symptoms
OSDI (Ocular Surface Disease Index)
Time frame: 1 day post-operative
Questionnaire assessing subjective dry eyes symptoms
OSDI (Ocular Surface Disease Index)
Time frame: 7 day post-operative
Questionnaire assessing subjective dry eyes symptoms
OSDI (Ocular Surface Disease Index)
Time frame: 1 month post-operative
Questionnaire assessing subjective dry eyes symptoms
OSDI (Ocular Surface Disease Index)
Time frame: 3 month post-operative
Questionnaire assessing subjective dry eyes symptoms
OSDI (Ocular Surface Disease Index)
Time frame: 1 year post-operative
Questionnaire assessing subjective dry eyes symptoms
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
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
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
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
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
Schirmer test without anesthesia
Time frame: Pre-operative
Tear film excretion examined using Whatman filter paper without anesthesia
Schirmer test without anesthesia
Time frame: 1 day post-operative
Tear film excretion examined using Whatman filter paper without anesthesia
Schirmer test without anesthesia
Time frame: 7 day post-operative
Tear film excretion examined using Whatman filter paper without anesthesia
Schirmer test without anesthesia
Time frame: 1 month post-operative
Tear film excretion examined using Whatman filter paper without anesthesia
Schirmer test without anesthesia
Time frame: 3 months post-operative
Tear film excretion examined using Whatman filter paper without anesthesia
Schirmer test without anesthesia
Time frame: 1 year post-operative
Tear film excretion examined using Whatman filter paper without anesthesia
Schirmer test with anesthesia
Time frame: Pre-operative
Tear film excretion examined using Whatman filter paper with anesthesia prior to examination
Schirmer test with anesthesia
Time frame: 1 day post-operative
Tear film excretion examined using Whatman filter paper with anesthesia prior to examination
Schirmer test with anesthesia
Time frame: 7 day post-operative
Tear film excretion examined using Whatman filter paper with anesthesia prior to examination
Schirmer test with anesthesia
Time frame: 1 month post-operative
Tear film excretion examined using Whatman filter paper with anesthesia prior to examination
Schirmer test with anesthesia
Time frame: 3 months post-operative
Tear film excretion examined using Whatman filter paper with anesthesia prior to examination
Schirmer test with anesthesia
Time frame: 1 year post-operative
Tear film excretion examined using Whatman filter paper with anesthesia prior to examination
Epitheliopathy
Time frame: Pre-operative
Epitheliopathy occurence, assessed with fluorescent dye and observed with cobalt blue light filter of slit lamp
Epitheliopathy
Time frame: 1 day post-operative
Epitheliopathy occurence, assessed with fluorescent dye and observed with cobalt blue light filter of slit lamp
Epitheliopathy
Time frame: 7 day post-operative
Epitheliopathy occurence, assessed with fluorescent dye and observed with cobalt blue light filter of slit lamp
Epitheliopathy
Time frame: 1 month post-operative
Epitheliopathy occurence, assessed with fluorescent dye and observed with cobalt blue light filter of slit lamp
Epitheliopathy
Time frame: 3 months post-operative
Epitheliopathy occurence, assessed with fluorescent dye and observed with cobalt blue light filter of slit lamp
Corneal exposure
Time frame: Pre-operative
Exposed distance of cornea when the eye was closed
Corneal exposure
Time frame: 1 day post-operative
Exposed distance of cornea when the eye was closed
Corneal exposure
Time frame: 7 day post-operative
Exposed distance of cornea when the eye was closed
Corneal exposure
Time frame: 1 month post-operative
Exposed distance of cornea when the eye was closed
Corneal exposure
Time frame: 3 months post-operative
Exposed distance of cornea when the eye was closed
Corneal sensibility
Time frame: Pre-operative
Sensibility measured in millimeters by using Luneau Cohcet-Bonnet Aesthesiometer
Corneal sensibility
Time frame: 1 day post-operative
Sensibility measured in millimeters by using Luneau Cohcet-Bonnet Aesthesiometer
Corneal sensibility
Time frame: 7 day post-operative
Sensibility measured in millimeters by using Luneau Cohcet-Bonnet Aesthesiometer
Corneal sensibility
Time frame: 1 month post-operative
Sensibility measured in millimeters by using Luneau Cohcet-Bonnet Aesthesiometer
Corneal sensibility
Time frame: 3 months post-operative
Sensibility measured in millimeters by using Luneau Cohcet-Bonnet Aesthesiometer
Complication
Time frame: intraoperative
Complication during surgery and after surgery
Complication
Time frame: 1 day post-operative
Complication during surgery and after surgery
Complication
Time frame: 7 day post-operative
Complication during surgery and after surgery
Complication
Time frame: 1 month post-operative
Complication during surgery and after surgery
Complication
Time frame: 3 months post-operative
Complication during surgery and after surgery
Complication
Time frame: 1 year post-operative
Complication during surgery and after surgery
Duration
Time frame: Intraoperative
Duration of surgery
Cost
Time frame: 1 year post-operative
Cost of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2021.
- Background: PubMed 20590416Pereira MV, Gloria AL. Lagophthalmos. Semin Ophthalmol. 2010 May;25(3):72-8. doi: 10.3109/08820538.2010.488578.
- Background: PubMed 20496572El Toukhy E. Gold weight implants in the management of lagophthalmos in leprosy patients. Lepr Rev. 2010 Mar;81(1):79-81.
- Background: PubMed 12831146Daniel 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.
- Background: PubMed 24786615Nemet AY. Augmentation of lateral tarsorrhaphy in lagophthalmos. Orbit. 2014 Aug;33(4):289-91. doi: 10.3109/01676830.2014.894537. Epub 2014 Apr 30.
- Background: PubMed 17449001Aggarwal 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.
- Background: PubMed 11711925Hontanilla 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.
- Background: PubMed 3507412Lamba PA, Srinivasan R, Rohatgi J. Surgical management in ocular leprosy. Indian J Ophthalmol. 1987 May-Jun;35(3):153-7. No abstract available.
- Background: PubMed 11875765Koshy 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.
- Background: PubMed 29677348Li 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.
- Background: PubMed 11347647Harrisberg 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.
- Background: PubMed 8534670Hieselaar 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.
- Background: PubMed 1995039Karacorlu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yunia Irawati, Ophthalmologist Consultant principal investigator
Universitas Indonesia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Tarsorrhaphy and Gold Weight Implant in people with Paralytic Lagophthalmos and Leprosy--Patients, run by Yunia Irawati at 3 sites in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lagophthalmos distance without pressure (time frame: Pre-operative). The study lists 58 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04944498, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2021.