Immediate Simultaneous Bilateral Cataract Surgery (ISBCS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Panhandle Eye Group, LLP
Sponsor:
Information provided by (Responsible Party):
Sloan W. Rush, MD, Panhandle Eye Group, LLP
ClinicalTrials.gov Identifier:
NCT01841957
First received: April 18, 2013
Last updated: April 24, 2013
Last verified: April 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Panhandle Eye Group, LLP:

Primary Outcome Measures:
  • Visual acuity [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 2000
Study Start Date: April 2013
Estimated Primary Completion Date: April 2016 (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

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Sloan W. Rush, MD, MD, Panhandle Eye Group, LLP
ClinicalTrials.gov Identifier: NCT01841957     History of Changes
Other Study ID Numbers: 2
Study First Received: April 18, 2013
Last Updated: April 24, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Panhandle Eye Group, LLP:
Bilateral Cataract
Simultaneous Cataract Surgery
ISBCS

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on October 19, 2014