Back to resultsImmediate Simultaneous Bilateral Cataract Surgery (ISBCS)
Primary Purpose
Bilateral Cataract
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ISBCS
DSBCS
Sponsored by
About this trial
This is an interventional treatment trial for Bilateral Cataract focused on measuring Bilateral Cataract, Simultaneous Cataract Surgery, ISBCS
Eligibility 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
Sites / Locations
- Panhandle Eye Group
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ISBCS
DSBCS
Arm Description
Immediate Simultaneous Bilateral Cataract Surgery
Delayed Sequential Bilateral Cataract Surgery
Outcomes
Primary Outcome Measures
Visual acuity
Best uncorrected and best spectacle corrected post-operative visual acuity
Secondary Outcome Measures
Recovery time and number of post-operative visits
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01841957
Brief Title
Immediate Simultaneous Bilateral Cataract Surgery
Acronym
ISBCS
Official Title
Immediate Simultaneous Bilateral Cataract Surgery: A Prospective, Case-controlled Clinical Trial in the United States
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
April 2013 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
April 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sloan W. Rush, MD
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bilateral Cataract
Keywords
Bilateral Cataract, Simultaneous Cataract Surgery, ISBCS
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ISBCS
Arm Type
Experimental
Arm Description
Immediate Simultaneous Bilateral Cataract Surgery
Arm Title
DSBCS
Arm Type
Active Comparator
Arm Description
Delayed Sequential Bilateral Cataract Surgery
Intervention Type
Procedure
Intervention Name(s)
ISBCS
Intervention Description
same-day cataract surgery
Intervention Type
Procedure
Intervention Name(s)
DSBCS
Intervention Description
bilateral surgery delayed by 1-3 weeks amongst eyes
Primary Outcome Measure Information:
Title
Visual acuity
Description
Best uncorrected and best spectacle corrected post-operative visual acuity
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Recovery time and number of post-operative visits
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Panhandle Eye Group
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Immediate Simultaneous Bilateral Cataract Surgery
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