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OpenTrials
Completed

NCT Number: NCT00801359

BSSPlus Versus Lactated Ringer's for Phacoemulsification

Two intraocular irrigating solutions (BSSPlus versus Lactated Ringer's) are compared in this prospective, randomized, masked trial to investigate for differences in preservation of corneal integrity after phacoemulsification cataract surgery.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto; Centro Avançado de Retina e Catarata

Ribeirão Preto, São Paulo, 14049-900, Brazil

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with senile cataract
  • Visual acuity between 20/400 and 20/40

Exclusion criteria

  • Presence of corneal opacity
  • Presence of corneal disease
  • Traumatic, toxic, hereditary (congenital)and complicated cataracts(uveitis)
  • Anterior chamber cells or flare detected before surgery
  • Previous ocular surgery
  • Any condition which may affect documentation or follow-up

Treatment and study plan

phacoemulsification

Procedure

BSSPlus solution

Drug

Lactated Ringer's solution

Drug

Primary outcomes

  1. endothelial cell density

    Time frame: baseline and at 1, 8, 15, 30 and 60 days postoperatively

  2. central corneal thickness

    Time frame: baseline and at 1, 8, 15, 30 and 60 days postoperatively

Secondary outcomes

  1. number of anterior chamber cells and flare grade

    Time frame: baseline and at 1, 8, 15, 30 and 60 days postoperatively

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

Comparison of Corneal Changes After Phacoemulsification Using BSSPlus Versus Lactated Ringer's Irrigating Solution

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Dec 3, 2008
Registry last updated
Dec 16, 2008

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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