Safety of NGOIS Compared to BSS Plus in Pediatric Patients

Alcon Research18 enrolled

Overview

To evaluate the Safety of Next Generation Ophthalmic Irrigating Solution compared to BSS Plus for use during cataract surgery in Pediatric patients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Cataract

Interventions

Next Generation Ophthalmic Irrigating Solution (NGOIS)DRUG

Volume sufficient to irrigate adequately during cataract surgery

BSS PlusDRUG

Volume sufficient to irrigate adequately during cataract surgery

Eligibility

Sex: ALLMin age: 1 WeekMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Cataract present. * Other protocol-defined inclusion criteria may apply. Exclusion Criteria: * As per age requirements. * Other protocol-defined exclusion criteria may apply.

Locations (1)

Contact Alcon for Trial Locations

Fort Worth, Texas, United States

Outcomes

Primary Outcomes

Safety Variables: Endothelial cell density, visual acuity, intraocular pressure, ocular signs and fundus assessment

Data from ClinicalTrials.gov

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