Effect of Prophylactic Ketorolac on CME After Cataract Su... | NCT00335439

Studies
Effect of Prophylactic Ketorolac on CME After Cataract Surgery

NCT00335439

Sponsor

Queen's University

Status

Completed

Last Update Posted

Jan 13, 2016Estimated

Enrollment

98Actual

Phase

Not Applicable

Conditions

Macular Edema, Cystoid

Interventions

ketorolac tromethamine 0.5% (Acular®)

Countries

Canada

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

Jan 2016

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

Jun 2006

Primary Completion Date

May 2007Actual

Completion Date

May 2007Actual

First Submitted Date

Jun 8, 2006

First Submission Date that Met QC Criteria

Jun 8, 2006

First Posted Date

Jun 9, 2006Estimated

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

Jan 12, 2016

Last Update Posted Date

Jan 13, 2016Estimated

Description Module

Brief Summary

The study will evaluate the efficacy of prophylactic administration of the topical nonsteroidal anti-inflammatory drug (NSAID) ketorolac tromethamine 0.5% (Acular®) on cystoid macular edema (CME) in patients having undergone cataract surgery. CME is the most frequent cause of decreased vision after uncomplicated cataract surgery and can result in irreversible sight reduction. The investigation will involve a comparison arm and a treatment arm with both sets of patient populations being evaluated for CME with ophthalmologic examinations and optical coherence tomography (OCT) measurements. The objective is to elucidate the role of NSAID drops in preventing CME after cataract surgery.

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

98Actual

Name	Type	Description	Arm Group Labels	Other Names
ketorolac tromethamine 0.5% (Acular®)	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Degree of cystoid macular edema by means of OCT (total macular volume) measurements

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

First cataract surgery (i.e., first eye).

Exclusion Criteria:

hypersensitivity to the NSAID drug class,
pregnancy.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sherif El-Defrawy, MD PhD FRCSC	Hotel Dieu Hospital, Kingston General Hospital, Queen's University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hotel Dieu Hospital		Kingston	Ontario	K7L 5G2	Canada

Condition Browse Module

MeSH Terms

ID	Term
D008269	Macular Edema

Ancestor Terms

ID	Term
D008268	Macular Degeneration
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020911	Ketorolac Tromethamine

Ancestor Terms

ID	Term
D007213	Indomethacin
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Browse Leaves

Not provided

Browse Branches

Not provided