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Immediate Simultaneous Bilateral Cataract Surgery (ISBCS)

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ClinicalTrials.gov Identifier: NCT01841957
Recruitment Status : Recruiting
First Posted : April 29, 2013
Last Update Posted : October 4, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Bilateral Cataract Procedure: ISBCS Procedure: DSBCS

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Immediate Simultaneous Bilateral Cataract Surgery: A Prospective, Case-controlled Clinical Trial in the United States
Study Start Date : April 2013
Estimated Primary Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Visual acuity [ Time Frame: 3 weeks ]
    Best uncorrected and best spectacle corrected post-operative visual acuity


Secondary Outcome Measures :
  1. Recovery time and number of post-operative visits [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01841957


Contacts
Contact: Sloan Rush, MD 806-353-0125
Contact: Sunday Fowler 806-353-0125

Locations
United States, Texas
Panhandle Eye Group Recruiting
Amarillo, Texas, United States, 79106
Contact: Sunday Fowler    806-353-0125      
Principal Investigator: Sloan Rush         
Sponsors and Collaborators
Sloan W. Rush, MD
More Information

Responsible Party: Sloan W. Rush, MD, MD, Panhandle Eye Group, LLP
ClinicalTrials.gov Identifier: NCT01841957     History of Changes
Other Study ID Numbers: 2
First Posted: April 29, 2013    Key Record Dates
Last Update Posted: October 4, 2016
Last Verified: October 2016

Keywords provided by Sloan W. Rush, MD, Panhandle Eye Group, LLP:
Bilateral Cataract
Simultaneous Cataract Surgery
ISBCS

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases