Topical 0.4% Ketorolac and Vitreoretinal Surgery

NCT ID: NCT00576329

Last Updated: 2014-05-14

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

PHASE2/PHASE3

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2007-10-31

Brief Summary

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To determine whether use of topical 0.4% ketorolac has any effect on pupil size during vitreoretinal surgery.

Detailed Description

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Other outcomes will be to assess postoperative pain and inflammation and visual acuity.

Conditions

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Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

Group Type PLACEBO_COMPARATOR

Ketorolac

Intervention Type DRUG

Topical use before surgery

B

Group Type EXPERIMENTAL

Ketorolac

Intervention Type DRUG

Topical use before surgery

Interventions

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Ketorolac

Topical use before surgery

Intervention Type DRUG

Other Intervention Names

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Acular LS

Eligibility Criteria

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Inclusion Criteria

* Age of 18, routine elective vitrectomy

Exclusion Criteria

* history of trauma, uveitis, prior intraocular surgery within 3 months, requirement of mechanical pupil dilation, prior inclusion of other eye
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Emory University

OTHER

Sponsor Role lead

Responsible Party

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Stephen Kim, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stephen J Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

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Emory Eye Clinic

Atlanta, Georgia, United States

Site Status

Countries

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United States

References

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Kim SJ, Lo WR, Hubbard GB 3rd, Srivastava SK, Denny JP, Martin DF, Yan J, Bergstrom CS, Cribbs BE, Schwent BJ, Aaberg TM Sr. Topical ketorolac in vitreoretinal surgery: a prospective, randomized, placebo-controlled, double-masked trial. Arch Ophthalmol. 2008 Sep;126(9):1203-8. doi: 10.1001/archopht.126.9.1203.

Reference Type DERIVED
PMID: 18779478 (View on PubMed)

Other Identifiers

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IRB00000517

Identifier Type: -

Identifier Source: org_study_id

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