NCT00576329

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for phase_2 surgery

Timeline
Completed

Started Nov 2006

Shorter than P25 for phase_2 surgery

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 19, 2007

Completed
Last Updated

May 14, 2014

Status Verified

May 1, 2014

First QC Date

December 17, 2007

Last Update Submit

May 12, 2014

Conditions

Surgery

Keywords

vitreoretinal surgery, ketorolac, Acular, mydriasis

Outcome Measures

Primary Outcomes (1)

  • Change in pupil size during vitreoretinal surgery

    Surgery

Secondary Outcomes (1)

  • Postoperative pain and inflammation

    1 day

Study Arms (2)

A

PLACEBO COMPARATOR
Drug: Ketorolac

B

EXPERIMENTAL
Drug: Ketorolac

Interventions

KetorolacDRUG

Topical use before surgery

Also known as: Acular LS
AB

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age of 18, routine elective vitrectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory Eye Clinic

Atlanta, Georgia, 30322, United States

Location

Related Publications (1)

  • 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.

    PMID: 18779478DERIVED

MeSH Terms

Conditions

Mydriasis

Interventions

Ketorolac

Condition Hierarchy (Ancestors)

Pupil DisordersEye Diseases

Intervention Hierarchy (Ancestors)

IndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Stephen J Kim, MD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 17, 2007

First Posted

December 19, 2007

Study Start

November 1, 2006

Study Completion

October 1, 2007

Last Updated

May 14, 2014

Record last verified: 2014-05

Locations

US(1)