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Trial record 1 of 1 for:    NCT01841957
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Immediate Simultaneous Bilateral Cataract Surgery (ISBCS)

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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

Study Description
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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 Phase
Bilateral Cataract Procedure: ISBCS Procedure: DSBCS Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 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
Actual Study Start Date : April 2013
Actual Primary Completion Date : April 1, 2022
Actual Study Completion Date : April 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arms and Interventions
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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
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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
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Ages Eligible for Study:   30 Years to 100 Years   (Adult, Older Adult)
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
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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


Locations
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United States, Texas
Panhandle Eye Group
Amarillo, Texas, United States, 79106
Sponsors and Collaborators
Sloan W. Rush, MD
More Information
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Responsible Party: Sloan W. Rush, MD, MD, Panhandle Eye Group, LLP
ClinicalTrials.gov Identifier: NCT01841957    
Other Study ID Numbers: 2
First Posted: April 29, 2013    Key Record Dates
Last Update Posted: April 28, 2022
Last Verified: April 2022
Keywords provided by Sloan W. Rush, MD, Panhandle Eye Group, LLP:
Bilateral Cataract
Simultaneous Cataract Surgery
ISBCS
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases