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Immediate Simultaneous Bilateral Cataract Surgery (ISBCS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01841957
Recruitment Status : Completed
First Posted : April 29, 2013
Last Update Posted : April 28, 2022
Sponsor:
Information provided by (Responsible Party):
Sloan W. Rush, MD, Panhandle Eye Group, LLP

Tracking Information
First Submitted Date  ICMJE April 18, 2013
First Posted Date  ICMJE April 29, 2013
Last Update Posted Date April 28, 2022
Actual Study Start Date  ICMJE April 2013
Actual Primary Completion Date April 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2013)
Visual acuity [ Time Frame: 3 weeks ]
Best uncorrected and best spectacle corrected post-operative visual acuity
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2013)
Recovery time and number of post-operative visits [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immediate Simultaneous Bilateral Cataract Surgery
Official Title  ICMJE Immediate Simultaneous Bilateral Cataract Surgery: A Prospective, Case-controlled Clinical Trial in the United States
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Bilateral Cataract
Intervention  ICMJE
  • Procedure: ISBCS
    same-day cataract surgery
  • Procedure: DSBCS
    bilateral surgery delayed by 1-3 weeks amongst eyes
Study Arms  ICMJE
  • Experimental: ISBCS
    Immediate Simultaneous Bilateral Cataract Surgery
    Intervention: Procedure: ISBCS
  • Active Comparator: DSBCS
    Delayed Sequential Bilateral Cataract Surgery
    Intervention: Procedure: DSBCS
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 20, 2022)
100
Original Estimated Enrollment  ICMJE
 (submitted: April 24, 2013)
2000
Actual Study Completion Date  ICMJE April 1, 2022
Actual Primary Completion Date April 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01841957
Other Study ID Numbers  ICMJE 2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Sloan W. Rush, MD, Panhandle Eye Group, LLP
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Sloan W. Rush, MD
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Panhandle Eye Group, LLP
Verification Date April 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP