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Effect of Preoperative Topical Ketorolac on Aqueous Cytokine Levels and Macular Thickness in Cataract Surgery Patients

Primary Purpose

Cystoid Macular Edema, Postoperative, Diabetes Mellitus

Status

Completed

Phase

Phase 4

Locations

Malaysia

Study Type

Interventional

Intervention

Ketorolac tromethamine ophthalmic solution 0.45%

About this trial

This is an interventional prevention trial for Cystoid Macular Edema, Postoperative focused on measuring diabetes mellitus, aqueous humor, inflammatory cytokines, cystoid macular edema, postoperative, nonsteroidal anti-inflammatory drugs

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Diabetic patient group

Type 2 diabetes mellitus with no diabetic retinopathy
If with co-morbid, controlled hypertension with no hypertensive crisis in recent six months
Listed for phacoemulsification cataract surgery

Non diabetic patient group

No history of diabetes
If with co-morbid, controlled hypertension with no hypertensive crisis in recent six months
Listed for phacoemulsification cataract surgery

Exclusion Criteria:

Smoker
Presence of immune disease, local or systemic inflammation
Presence of retinal diseases, glaucoma
Previous surgical procedure on the eye
Intra-operative complications

Sites / Locations

University of Malaya

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

No Intervention

Active Comparator

No Intervention

Arm Label

Diabetes mellitus patients

Diabetes mellitus control patients

Non diabetic patients

Non diabetic control patients

Arm Description

Ketorolac tromethamine ophthalmic solution 0.45% four times a day for 3 days prior to cataract surgery

Topical refresh plus four times a day for 3 days prior to cataract surgery

Ketorolac tromethamine ophthalmic solution 0.45% four times a day for 3 days prior to cataract surgery

Topical refresh plus four times a day for 3 days prior to cataract surgery

Outcomes

Primary Outcome Measures

Level of aqueous inflammatory cytokines post treatment as assessed using Bio-plex Pro Assays

Aqueous samples were analyzed at the same after complete samples collection.

Secondary Outcome Measures

Changes from baseline in central subfield retinal thickness as assessed by optical coherence tomography

Full Information

NCT ID

NCT02646072

First Posted

December 12, 2015

Last Updated

January 4, 2016

Sponsor

University of Malaya

1. Study Identification

Unique Protocol Identification Number

NCT02646072

Brief Title

Effect of Preoperative Topical Ketorolac on Aqueous Cytokine Levels and Macular Thickness in Cataract Surgery Patients

Official Title

The Effect of Preoperative Topical Ketorolac 0.45% on Aqueous Cytokine Levels and Macular Thickness in Diabetic and Non Diabetic Patients Undergoing Cataract Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Completed

Study Start Date

August 2014 (undefined)

Primary Completion Date

May 2015 (Actual)

Study Completion Date

June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Malaya

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to determine whether there is a relationship between inflammatory cytokines in the aqueous of the eye and thickness of the macula after treatment of topical ketorolac for patients undergoing cataract surgery.

Detailed Description

To compare aqueous levels of inflammatory cytokines in diabetic and non diabetic patients treated with preoperative topical ketorolac tromethamine 0.45%. To compare the macular thickness changes in diabetic and non diabetic patients treated with preoperative ketorolac tromethamine 0.45% and its correlation with the aqueous inflammatory cytokines.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cystoid Macular Edema, Postoperative, Diabetes Mellitus

Keywords

diabetes mellitus, aqueous humor, inflammatory cytokines, cystoid macular edema, postoperative, nonsteroidal anti-inflammatory drugs

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Diabetes mellitus patients

Arm Type

Active Comparator

Arm Description

Ketorolac tromethamine ophthalmic solution 0.45% four times a day for 3 days prior to cataract surgery

Arm Title

Diabetes mellitus control patients

Arm Type

No Intervention

Arm Description

Topical refresh plus four times a day for 3 days prior to cataract surgery

Arm Title

Non diabetic patients

Arm Type

Active Comparator

Arm Description

Ketorolac tromethamine ophthalmic solution 0.45% four times a day for 3 days prior to cataract surgery

Arm Title

Non diabetic control patients

Arm Type

No Intervention

Arm Description

Topical refresh plus four times a day for 3 days prior to cataract surgery

Intervention Type

Drug

Intervention Name(s)

Ketorolac tromethamine ophthalmic solution 0.45%

Other Intervention Name(s)

Acuvail

Intervention Description

Indicated for the treatment of pain and inflammation following cataract surgery.

Primary Outcome Measure Information:

Title

Level of aqueous inflammatory cytokines post treatment as assessed using Bio-plex Pro Assays

Description

Aqueous samples were analyzed at the same after complete samples collection.

Time Frame

9 months

Secondary Outcome Measure Information:

Title

Changes from baseline in central subfield retinal thickness as assessed by optical coherence tomography

Time Frame

9 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diabetic patient group Type 2 diabetes mellitus with no diabetic retinopathy If with co-morbid, controlled hypertension with no hypertensive crisis in recent six months Listed for phacoemulsification cataract surgery Non diabetic patient group No history of diabetes If with co-morbid, controlled hypertension with no hypertensive crisis in recent six months Listed for phacoemulsification cataract surgery Exclusion Criteria: Smoker Presence of immune disease, local or systemic inflammation Presence of retinal diseases, glaucoma Previous surgical procedure on the eye Intra-operative complications

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yin Peng Lai, MOphthal

Organizational Affiliation

University of Malaya

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Mohammadreza Peyman, Mophthal

Organizational Affiliation

University of Malaya

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Tajunisah Iqbal, FRCS Ophth

Organizational Affiliation

University of Malaya

Official's Role

Study Director

Facility Information:

Facility Name

University of Malaya

City

Kuala Lumpur

State/Province

Wilayah Persekutuan

ZIP/Postal Code

50603

Country

Malaysia

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

22511846

Citation

Cheung CM, Vania M, Ang M, Chee SP, Li J. Comparison of aqueous humor cytokine and chemokine levels in diabetic patients with and without retinopathy. Mol Vis. 2012;18:830-7. Epub 2012 Apr 4.

Results Reference

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Citation

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Results Reference

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PubMed Identifier

24319335

Citation

Chu L, Wang B, Xu B, Dong N. Aqueous cytokines as predictors of macular edema in non-diabetic patients following uncomplicated phacoemulsification cataract surgery. Mol Vis. 2013 Nov 24;19:2418-25. eCollection 2013.

Results Reference

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22094296

Citation

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Citation

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Effect of Preoperative Topical Ketorolac on Aqueous Cytokine Levels and Macular Thickness in Cataract Surgery Patients

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