Immediate Simultaneous Bilateral Cataract Surgery

NCT ID: NCT01841957

Last Updated: 2022-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2022-04-01

Brief Summary

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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

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Conditions

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Bilateral Cataract

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ISBCS

Immediate Simultaneous Bilateral Cataract Surgery

Group Type EXPERIMENTAL

ISBCS

Intervention Type PROCEDURE

same-day cataract surgery

DSBCS

Delayed Sequential Bilateral Cataract Surgery

Group Type ACTIVE_COMPARATOR

DSBCS

Intervention Type PROCEDURE

bilateral surgery delayed by 1-3 weeks amongst eyes

Interventions

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ISBCS

same-day cataract surgery

Intervention Type PROCEDURE

DSBCS

bilateral surgery delayed by 1-3 weeks amongst eyes

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sloan W. Rush, MD

OTHER

Sponsor Role lead

Responsible Party

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Sloan W. Rush, MD

MD

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Panhandle Eye Group

Amarillo, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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2

Identifier Type: -

Identifier Source: org_study_id

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