High-dose subconjunctival cyclosporine a implants do not affect corneal neovascularization after high-risk keratoplasty.
Ophthalmology
; 121(9): 1677-82, 2014 Sep.
Article
em En
| MEDLINE
| ID: mdl-24780407
ABSTRACT
PURPOSE:
To test whether subconjunctival cyclosporine A (CsA) implants affect the incidence and the degree of corneal neovascularization occurring after penetrating keratoplasty.DESIGN:
Prospective, randomized, multicenter, controlled phase 2/3 clinical trial. The study comprised 43 trial sites in Germany, India, and the United States.PARTICIPANTS:
Enrolled patients (n = 97) were randomized to 1 of 3 groups treatment group A (n = 36), treatment group B (n = 40), and the control group (n = 21).METHODS:
Patients from each group received either of 2 doses of subconjunctival CsA (group A, low-dose CsA; group B, high-dose CsA) or placebo (carrier only) implants at the time of high-risk penetrating keratoplasty. MAIN OUTCOMEMEASURES:
The incidence and degree of corneal neovascularization occurring after penetrating keratoplasty were evaluated in a substudy (LX201-01 study NCT00447187). A web-based image upload system was developed. Standardized digital slit-lamp pictures were quantitatively and objectively evaluated using CellËF morphometry software.RESULTS:
No statistically significant difference in incidence and degree of corneal neovascularization developing after penetrating keratoplasty was found between treatment groups and placebo group. Mean corneal neovascularization area at week 52 (visit 12) was 2.32±1.79% in treatment group A versus placebo (2.79±2.11%; P = 0.45) and 2.74±2.22% in treatment group B versus placebo (2.79±2.11%; P = 0.94).CONCLUSIONS:
High-dose subconjunctival CsA implants do not significantly affect corneal neovascularization after high-risk penetrating keratoplasty. This suggests that local CsA has negligible antiangiogenic effects in the human cornea, at least in the transplant setting.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Ceratoplastia Penetrante
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Ciclosporina
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Neovascularização da Córnea
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Imunossupressores
Tipo de estudo:
Clinical_trials
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Etiology_studies
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Incidence_studies
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Observational_studies
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Prognostic_studies
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Risk_factors_studies
Limite:
Female
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Humans
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Male
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Middle aged
País como assunto:
America do norte
/
Asia
/
Europa
Idioma:
En
Ano de publicação:
2014
Tipo de documento:
Article