Ishfaq Ahmad Sofi1, Satish K Gupta2, Anuradha Bharti3, Tariq G Tantry4. 1. MBBS, MS. Registrar, Postgraduate Department of Ophthalmology, Government Medical College Srinagar. 2. MBBS, MS. Professor, Postgraduate Department of Ophthalmology, Government Medical College Jammu. 3. MBBS, MS. Senior resident, Postgraduate Department of Ophthalmology, Government Medical College Jammu. 4. MBBS, Junior resident, Postgraduate Department of Ophthalmology, Government Medical College Srinagar.
Abstract
OBJECTIVES: To assess the role, efficacy and tolerability of levodopa-carbidopa in the management of small and older children with different types of amblyopia. METHODOLOGY: Prospective randomised placebo controlled clinical study, in which 50 amblyopic patients between 5 and 20 years of age with visual acuity (V/A) < 20/40 were included, was carried on. After having attained the best possible refractive correction, patients were randomly divided into 2 groups. They were prescribed levodopa-carbidopa (10:1) (4-6mg/kg/day in 2-3 divided doses) or placebo, plus full-time occlusion of the sound eye, for a period of three months. Assessment of improvement in V/A, compliance and tolerance was done at follow up visits. Data was analyzed using computer software Ms-Excel and Epi-Info Version 6.0. The statistical significance was assessed by Chi-Square/Fisher's Exact Test. RESULTS:Visual acuity for the amblyopic eye improved significantly in both groups but there was significant improvement in group 1 than group 2 (P = 0.0001). In a subgroup of patients older than 12 years, levodopa group showed statistically significant improvement in baseline V/A (P = 0.0001). In patients with severe amblyopia, each group showed significant improvement in baseline V/A (p < 0.05), but was significantly more in group 1 (P = 0.0001). Compliance rates were similar among the groups and levodopa-carbidopa at a dose range of 4-6 mg/kg/day was well tolerated. CONCLUSION:Levodopa-carbidopa can be used as an adjunct to conventional occlusion therapy in amblyopia particularly in older children and severe cases of amblyopia, and it is well tolerated.
RCT Entities:
OBJECTIVES: To assess the role, efficacy and tolerability of levodopa-carbidopa in the management of small and older children with different types of amblyopia. METHODOLOGY: Prospective randomised placebo controlled clinical study, in which 50 amblyopic patients between 5 and 20 years of age with visual acuity (V/A) < 20/40 were included, was carried on. After having attained the best possible refractive correction, patients were randomly divided into 2 groups. They were prescribed levodopa-carbidopa (10:1) (4-6mg/kg/day in 2-3 divided doses) or placebo, plus full-time occlusion of the sound eye, for a period of three months. Assessment of improvement in V/A, compliance and tolerance was done at follow up visits. Data was analyzed using computer software Ms-Excel and Epi-Info Version 6.0. The statistical significance was assessed by Chi-Square/Fisher's Exact Test. RESULTS: Visual acuity for the amblyopic eye improved significantly in both groups but there was significant improvement in group 1 than group 2 (P = 0.0001). In a subgroup of patients older than 12 years, levodopa group showed statistically significant improvement in baseline V/A (P = 0.0001). In patients with severe amblyopia, each group showed significant improvement in baseline V/A (p < 0.05), but was significantly more in group 1 (P = 0.0001). Compliance rates were similar among the groups and levodopa-carbidopa at a dose range of 4-6 mg/kg/day was well tolerated. CONCLUSION:Levodopa-carbidopa can be used as an adjunct to conventional occlusion therapy in amblyopia particularly in older children and severe cases of amblyopia, and it is well tolerated.
Authors: Antonio Algaze; Lawrence E Leguire; Cynthia Roberts; James W Ibinson; Jennifer R Lewis; Gary Rogers Journal: J AAPOS Date: 2005-06 Impact factor: 1.220
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