Efficacy of Topical Cysteamine in Nephropathic Cyctinosis
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|ClinicalTrials.gov Identifier: NCT02766855|
Recruitment Status : Completed
First Posted : May 10, 2016
Last Update Posted : May 10, 2016
The Eye Center and The Eye Foundation for Research in Ophthalmology
Information provided by (Responsible Party):
Samir S. Shoughy, MD, FRCS (Glasg.), The Eye Center and The Eye Foundation for Research in Ophthalmology
The aim of this study is to evaluate the efficacy of topical cysteamine eye drops in the treatment of corneal cystine crystals deposits in patients with nephropathic cystinosis.
|Condition or disease||Intervention/treatment||Phase|
|Nephropathic Cyctinosis Corneal Cystine Crystals||Drug: Cysteamine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||January 2004|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||March 2016|
Experimental: cysteamine eye drops
Patients used cysteamine eye drops every 2 hours while awake to both eyes.
Patients were asked to use topical cysteamine 0.55% eye drops every 2 hours while awake to both eyes.
Primary Outcome Measures :
- Number of participants with improvement of photophobia, corneal cystine crystals and visual acuity following treatment with topical cysteamine 0.55% eye drops in patients with nephropathic cystinosis. [ Time Frame: Photophobia, slit lamp assessment of corneal cystine crystals and visual acuity are recorded pretreatment, on each monthly visit up to 48 months. ]Patients had a baseline ophthalmic examination before initiation of topical cysteamine 0.55% eye drops and subsequent monthly follow up exams. The following parameters were recorded pretreatment, on each monthly visit and post treatment at last follow up visit: photophobia, slit lamp assessment of corneal cystine crystals and visual acuity. Photophobia was classified as grade 0 (none) for no photophobia, grade 1 (mild) for photophobia in bright light, grade 2 (moderate) for photophobia in room light and grade 3 (severe) for photophobia in dim light. Corneal cystine crystals were graded as Grade 0 = None, Grade 1 = 1-10 crystals/mm, Grade 2 = 11- 50 crystals/mm, Grade 3 = more than 50 crystals/mm. The level of cystine in the corneal layers was recorded and the location whether peripheral or central was also identified. Visual acuity was measured by Snellen chart at 20 feet with best distance correction.
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