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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Patients who received surgery with modified tarsorrhaphy technique |
|
| Control group | Active Comparator | Patients who received surgery with gold weight implant technique |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified Tarsorrhaphy | Procedure | A combination of levator recess, lateral tarsorrhaphy of 10 mm, and lateral canthopexy/lateral tarsal strip |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yunia Irawati, Ophthalmologist Consultant | Indonesia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jakarta Eye Center Hospitals and Clinics | Jakarta | DKI Jakarta | 10310 | Indonesia | ||
| dr. Cipto Mangunkusumo Kirana Eye Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20590416 | Background | Pereira MV, Gloria AL. Lagophthalmos. Semin Ophthalmol. 2010 May;25(3):72-8. doi: 10.3109/08820538.2010.488578. | |
| 20496572 | Background | El Toukhy E. Gold weight implants in the management of lagophthalmos in leprosy patients. Lepr Rev. 2010 Mar;81(1):79-81. |
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| ID | Term |
|---|---|
| D000092164 | Lagophthalmos |
| D007918 | Leprosy |
| ID | Term |
|---|---|
| D005132 | Eye Manifestations |
| D005128 | Eye Diseases |
| D005141 | Eyelid Diseases |
| D009165 | Mycobacterium Infections, Nontuberculous |
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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.
| Gold Weight Implant | Procedure | Installation of 1,5 gram gold weight implant above tarsal plate and underneath levator recess |
|
| 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 |
| Jakarta Pusat |
| DKI Jakarta |
| 10320 |
| Indonesia |
| dr. Tadjuddin Chalid General Hospital | Makassar | South Sulawesi | 90241 | Indonesia |
| 12831146 | Background | 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. |
| 24786615 | Background | 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. |
| 17449001 | Background | 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. |
| 11711925 | Background | 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. |
| 3507412 | Background | Lamba PA, Srinivasan R, Rohatgi J. Surgical management in ocular leprosy. Indian J Ophthalmol. 1987 May-Jun;35(3):153-7. No abstract available. |
| 11875765 | Background | 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. |
| 29677348 | Background | 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. |
| 11347647 | Background | 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. |
| 8534670 | Background | 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. |
| 1995039 | Background | 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. |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |