| CTRI Number |
CTRI/2009/091/001078 [Registered on: 08/03/2010] |
| Last Modified On: |
|
| Post Graduate Thesis |
|
| Type of Trial |
|
|
Type of Study
|
|
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the efficacy of Acular LS eyedrops in preventing thickening of the retina due to edema after cataract surgery. "Acular LS CME Study (ALCS)" |
|
Scientific Title of Study
|
Randomised , triple blinded, placebo controlled, clinical trial to compare the effect of Ketorolac tromethamine 0.4% in prophylactically preventing Cystoid Macula Edema following Cataract Surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Abhishek Hoshing |
| Designation |
|
| Affiliation |
|
| Address |
Dept. of Ophthalmology
Schell Eye Hospital, Arni Road
Vellore
TAMIL NADU
632001
India |
| Phone |
0416-2281201 |
| Fax |
|
| Email |
abhishekhoshing@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Pushpa Jacob |
| Designation |
|
| Affiliation |
|
| Address |
Dept. of Ophthalmology
Schell Eye Hospital, Arni Road
Vellore
TAMIL NADU
632001
India |
| Phone |
0416-2281201 |
| Fax |
|
| Email |
pushpa_jacob@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Abhishek Hoshing |
| Designation |
|
| Affiliation |
|
| Address |
Dept. of Ophthalmology
Schell Eye Hospital, Arni Road
Vellore
TAMIL NADU
632001
India |
| Phone |
0416-2281201 |
| Fax |
|
| Email |
abhishekhoshing@gmail.com |
|
|
Source of Monetary or Material Support
|
| Allergan India limited will provide the unmarked bottles of Acular LS and Placebo |
| The FLUID Research Grant Committee of Christian Medical College and Hospital, Vellore, Tamil Nadu |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
|
| Type of Sponsor |
|
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Abhishek Hoshing |
Department of Ophthalmolog |
Schell Eye Hospital,Arni Road-632001
Vellore
TAMIL NADU |
0416-2281201
ahoshing@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee and Institutional Review Board of Christian Medical College And Hospital, Vellore, Tamil Nadu |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Post Small Incision Cataract Surgery (Pseudophakic) Acute Cystoid Macular Edema, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ketorolac tromethamine eye drops 0.4% |
one drop 4 times in a day for 2 months |
| Comparator Agent |
Polyvinyl Alcohol 14mg/ml (Tear Substitute) |
One drop 4 times a day for 2 months |
|
|
Inclusion Criteria
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
Adult males and females 50-70 years of age coming for cataract surgery to our hospital.
Staying within 40 kms of Vellore town. |
|
| ExclusionCriteria |
| Details |
Inabiltity to visualise the macula preoperatively in the eye to be operated.
Ocular disease that can affect macular function.
Uncontrolled Diabetics defined by RBS/PP Sugars > 200mg/dl.
Diabetic Maculopathy with Edema in eye to be operated.
Past History of intraocular surgery in the eye under consideration.
History of use of Topical steroid drops or NSAID drops within the past 30 days prior to enrolment.
Current use of Oral steroids.
Known NSAIDs Allergy. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Acute Pseudophakic Cystoid Macular Edema |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="704"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
08/02/2010 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
|
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a Randomised , triple blinded, parallel group, placebo controlled trial to assess the efficacy of Ketorolac Tromethamine 0.4% eye drops (1 drop 4 times a day for 2 months) in prophylactically preventing Acute Pseudophakic Cystoid Macular Edema as compared to a placebo. The study will be conducted at 1 site only in the Department of Ophthalmology of a Tertiary care level hospital and will randomise 704 patients to the two protocols (352 in each arm). The primary outcome will be occurrence of Cystoid Macular Edema in post cataract surgery patients measured clinically with visual acuity and fundus examination with Slit Lamp Biomicroscopy and also with Optical Coherence Tomography (Fast Macula scan) |