Immediate Simultaneous Bilateral Cataract Surgery (ISBCS)

April 20, 2022 updated by: Sloan W. Rush, MD

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Amarillo, Texas, United States, 79106
        • panhandle eye group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ISBCS
Immediate Simultaneous Bilateral Cataract Surgery
Procedure: ISBCS
same-day cataract surgery
ACTIVE_COMPARATOR: DSBCS
Delayed Sequential Bilateral Cataract Surgery
Procedure: DSBCS
bilateral surgery delayed by 1-3 weeks amongst eyes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual acuity
Time Frame: 3 weeks
Best uncorrected and best spectacle corrected post-operative visual acuity
3 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Recovery time and number of post-operative visits
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sloan W. Rush, MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2013

Primary Completion (ACTUAL)

April 1, 2022

Study Completion (ACTUAL)

April 1, 2022

Study Registration Dates

First Submitted

April 18, 2013

First Submitted That Met QC Criteria

April 24, 2013

First Posted (ESTIMATE)

April 29, 2013

Study Record Updates

Last Update Posted (ACTUAL)

April 28, 2022

Last Update Submitted That Met QC Criteria

April 20, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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