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Completed

NCT Number: NCT00333203

Next Generation Ophthalmic Irrigating Solution Posterior Segment Study

The purpose of this study is to evaluate the safety of Next Generation Ophthalmic Irrigating Solution (NGOIS) compared to BSS PLUS for use during surgery for removal of epimacular membrane and vitrectomy.

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Key information

Conditions

Eye Diseases Epiretinal Membrane Retinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

United States

Fort Worth, Texas, 76134, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients of any race and sex, with an epimacular membrane who would benefit from vitrectomy and membrane removal.
  • Other protocol-defined inclusion criteria may apply.

Exclusion criteria

  • Under 18 years of age.
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

Next Generation Ophthalmic Irrigating Solution (NGOIS)

Drug

Volume sufficient to irrigate adequately during cataract surgery

BSS Plus

Other

Volume sufficient to irrigate adequately during cataract surgery

Primary outcomes

  1. Best-corrected logMAR visual acuity

Secondary outcomes

  1. Intraocular pressure (IOP)

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Clinical Evaluation of the Safety of Next Generation Ophthalmic Irrigating Solution Compared to BSS Plus for Use During Surgery for Removal of Epimacular Membrane and Vitrectomy

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Jun 2, 2006
Registry last updated
Mar 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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