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OpenTrials
Completed

NCT Number: NCT01841957

Immediate Simultaneous Bilateral Cataract Surgery

To evaluate the safety and efficacy of treating visually significant bilateral cataract with the newer technique of Immediate Simultaneous Bilateral Cataract Surgery (ISBCS) versus the conventional technique of Delayed Sequential Bilateral Cataract Surgery (DSBCS) in a select patient population.

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Key information

Conditions

Bilateral Cataract Cataract Eye Diseases Lens Diseases

Age range

30 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Panhandle Eye Group

Amarillo, Texas, 79106, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 30-100
  • Candidate for topical anesthesia
  • Signed the informed consents

Exclusion criteria

  • Allergies to medications used in study
  • Cannot have topical anesthesia
  • Unwilling to participate in research trial
  • Have any other significant ocular comorbidities
  • Have known systemic immuno-compromised state

Treatment and study plan

ISBCS

Procedure

same-day cataract surgery

DSBCS

Procedure

bilateral surgery delayed by 1-3 weeks amongst eyes

Primary outcomes

  1. Visual acuity

    Time frame: 3 weeks

    Best uncorrected and best spectacle corrected post-operative visual acuity

Secondary outcomes

  1. Recovery time and number of post-operative visits

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Sloan W. Rush, MD

Other

Registry information

Official study title

Immediate Simultaneous Bilateral Cataract Surgery: A Prospective, Case-controlled Clinical Trial in the United States

Acronym: ISBCS

Important dates

Study start
2013
Primary completion
2022
Study completion
2022
First posted
Apr 29, 2013
Registry last updated
Apr 28, 2022

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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