NCT00348244

Brief Summary

Evaluate if the incidence of sub clinical CME can be significantly reduced by use of peri-operative Acular LS plus Pred Forte when compared with Pred Forte alone in normal cataract patients.

Trial Health

80
On Track

Trial Health Score

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

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

First Submitted

Initial submission to the registry

June 30, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 4, 2006

Completed
Last Updated

January 17, 2007

Status Verified

January 1, 2007

First QC Date

June 30, 2006

Last Update Submit

January 15, 2007

Conditions

Cataract

Interventions

Ketorolac, Prednisolone AcetateDRUG

Eligibility Criteria

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

You may qualify if:

  • · Male or female \> 18 years of age scheduled to undergo cataract surgery with surgeon expectation of 20/20 BCVA postoperatively
  • Must be in good general health. Patients with systemic diseases will be enrolled only if there are no ocular manifestations of their disease (ie diabetics with normal retinal exams)
  • Ability to provide informed consent and likely to complete all study visits

You may not qualify if:

  • · Known contraindication to any study medication or any of their components
  • Uncontrolled systemic disease
  • Required use of ocular medications other than the study medications during the study
  • Abnormal pre-operative OCTs if obtainable
  • Diabetic patients with a history of macular edema or diabetic retinopathy
  • AMD patients with less than a 20/20 surgical outcome expectation, epi-retinal membranes, retinal vein occlusion, or any pre-existing macular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Wittpenn

Stony Brook, New York, 11790, United States

Location

Related Publications (1)

  • Wittpenn JR, Silverstein S, Heier J, Kenyon KR, Hunkeler JD, Earl M; Acular LS for Cystoid Macular Edema (ACME) Study Group. A randomized, masked comparison of topical ketorolac 0.4% plus steroid vs steroid alone in low-risk cataract surgery patients. Am J Ophthalmol. 2008 Oct;146(4):554-560. doi: 10.1016/j.ajo.2008.04.036. Epub 2008 Jul 2.

    PMID: 18599019DERIVED

MeSH Terms

Conditions

Cataract

Interventions

Ketorolacprednisolone acetate

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • John Wittpenn, MD

    Ophthalmic Consultants of Long Island

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 30, 2006

First Posted

July 4, 2006

Last Updated

January 17, 2007

Record last verified: 2007-01

Locations

US(1)