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Immediate Simultaneous Bilateral Cataract Surgery (ISBCS)

This study is currently recruiting participants.
Verified October 2016 by Sloan W. Rush, MD, Panhandle Eye Group, LLP
Sponsor:
ClinicalTrials.gov Identifier:
NCT01841957
First Posted: April 29, 2013
Last Update Posted: October 4, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Sloan W. Rush, MD, Panhandle Eye Group, LLP
  Purpose
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 Intervention
Bilateral Cataract Procedure: ISBCS Procedure: DSBCS

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Sloan W. Rush, MD, Panhandle Eye Group, LLP:

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


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

Estimated Enrollment: 2000
Study Start Date: April 2013
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 Submitted: April 18, 2013
First Posted: April 29, 2013
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