Immediate Simultaneous Bilateral Cataract Surgery | NCT01841957

Studies
Immediate Simultaneous Bilateral Cataract Surgery

NCT01841957

Sponsor

Sloan W. Rush, MD

Status

Completed

Last Update Posted

Apr 28, 2022Actual

Enrollment

100Actual

Phase

Not Applicable

Conditions

Bilateral Cataract

Interventions

ISBCS
DSBCS

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2013Actual

Primary Completion Date

Apr 1, 2022Actual

Completion Date

Apr 1, 2022Actual

First Submitted Date

Apr 18, 2013

First Submission Date that Met QC Criteria

Apr 24, 2013

First Posted Date

Apr 29, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 20, 2022

Last Update Posted Date

Apr 28, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ISBCS	Experimental	Immediate Simultaneous Bilateral Cataract Surgery	Procedure: ISBCS
DSBCS	Active Comparator	Delayed Sequential Bilateral Cataract Surgery	Procedure: DSBCS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ISBCS	Procedure	same-day cataract surgery	ISBCS
DSBCS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual acuity	Best uncorrected and best spectacle corrected post-operative visual acuity	3 weeks

Secondary Outcomes

Measure	Description	Time Frame
Recovery time and number of post-operative visits		6 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Panhandle Eye Group		Amarillo	Texas	79106	United States

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases