Trial reportClinics (Sao Paulo, Brazil)2025
Outcomes of Susanna UF implants in refractory congenital glaucoma.
Trial report in Clinics (Sao Paulo, Brazil), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
objectiveThis study aimed to evaluate the success and complication rates of the Susanna UF Glaucoma Drainage Device (SUFGDD) in treating refractory primary congenital glaucoma. PATIENTS AND
methodsIn this prospective non-comparative clinical trial, patients with refractory primary congenital glaucoma, under 18-years-old, who had unsuccessful prior glaucoma surgeries, underwent standardized SUFGDD implant surgery. All procedures were performed by a single surgeon (A.D.P.R.). Pre and postoperative intraocular pressure (IOP), number of antiglaucoma eye drops, surgical complications, and any subsequent related events were recorded. Success criteria were defined as follows: (I) IOP ≥ 5 and ≤ 21 mmHg; (II) IOP ≥ 5 and ≤ 18 mmHg. Each group was further categorized as absolute success (without medication) or qualified success (including those with medication).
resultsThe study included 45 eyes from 31 patients, with an average age of 6.14 ± 5.02 years (range: 9 months‒18 years). The mean follow-up time was 37.78 ± 10.44 months. Mean IOP decreased from 28.18 ± 5.69 mmHg to 14.73 ± 2.90 mmHg (p < 0.05). The average number of antiglaucoma medications was reduced from 2.96 ± 0.74 to 1.40 ± 1.23 (p < 0.05). At 36-months postoperatively, the qualified success rates for criteria I and II were 93.3 % and 77.8 %, respectively. Seven eyes (15.6 %) experienced complications, all of which required reoperation; six cases were successfully managed, while one case resulted in permanent vision loss due to endophthalmitis. There were no significant associations between complications and analyzed risk factors (e.g., number of previous surgeries, age at surgery, past glaucoma surgeries, preoperative IOP, and number of preoperative eye drops). However, an association was observed between the occurrence of complications and surgical failure in the qualified success group for criterion II (HR = 6.50; 95 % CI 1.20‒31.35; p = 0.029).
conclusionIn this studied cohort, SUFGDD achieved qualified success rates of 93.3 % and 77.8 %, for criteria I and II, respectively, at 36-months, with a complication rate of 15.6 %.
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