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CTRI Number  CTRI/2016/04/006806 [Registered on: 07/04/2016] Trial Registered Retrospectively
Last Modified On: 02/04/2016
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Need for steroid use after routine cataract surgery 
Scientific Title of Study   Are steroids required to control post-operative inflammation after uncomplicated phacoemulsification surgery? 
Trial Acronym  SEC08201301 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bhaskar Ray Chaudhuri 
Designation  Director 
Affiliation  The Calcutta Medical Research Institute 
Address  The Calcutta Medical Research Institute 7/2 Diamond Harbour Road Kolkata 700027
The Calcutta Medical Research Institute 7/2 Diamond Harbour Road Kolkata 700027
Kolkata
WEST BENGAL
700027
India 
Phone  09830024939  
Fax    
Email  brc_cmri@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bhaskar Ray Chaudhuri 
Designation  Director 
Affiliation  The Calcutta Medical Research Institute 
Address  The Calcutta Medical Research Institute 7/2 Diamond Harbour Road Kolkata 700027
The Calcutta Medical Research Institute 7/2 Diamond Harbour Road Kolkata 700027
Kolkata
WEST BENGAL
700027
India 
Phone  09830024939  
Fax    
Email  brc_cmri@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Bhaskar Ray Chaudhuri 
Designation  Director 
Affiliation  The Calcutta Medical Research Institute 
Address  The Calcutta Medical Research Institute 7/2 Diamond Harbour Road Kolkata 700027
The Calcutta Medical Research Institute 7/2 Diamond Harbour Road Kolkata 700027
Kolkata
WEST BENGAL
700027
India 
Phone  09830024939  
Fax    
Email  brc_cmri@yahoo.com  
 
Source of Monetary or Material Support  
Allergan India Private Limited 
The Calcutta Medical Research Institute 
 
Primary Sponsor  
Name  The Calcutta Medical Research Institute 
Address  7/2 Diamond Harbour Road Kolkata West Bengal 700027 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
Allergan India Private Limited  Level 2, Prestige Obelisk No. 2 Kasturba Road Bengaluru Karnataka 560001 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Bhaskar Ray Chaudhuri  The Calcutta Medical Research Institute  7/2 Diamond Harbour Road Kolkata 700027
South Twentyfour Parganas
WEST BENGAL 
9830024939

brc_cmri@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, The CMRI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Those undergoing cataract surgery by standard phacoemulsification and hydrophobic foldable intraocular lens implantation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  ketorolac tromethamine ophthalmic solution) 0.45%  INDICATIONS AND USAGE Ketorolac Tromethamine ophthalmic solution is a nonsteroidal, antiinflammatory indicated for the treatment of pain and inflammation following cataract surgery. DOSAGE AND ADMINISTRATION One drop should be applied by the patient to the affected eye twice daily. 
Comparator Agent  prednisolone acetate ophthalmic suspension 1%  Chemical Name: 11ß,17, 21-Trihydroxypregna-1,4-diene-3, 20-dione 21-acetate Contains: Active: prednisolone acetate (microfine suspension) 1% Preservative: benzalkonium chloride. Inactives: boric acid; edetate disodium; hypromellose; polysorbate 80; purified water; sodium bisulfite; sodium chloride; and sodium citrate. The pH during its shelf life ranges from 5.0 - 6.0. CLINICAL PHARMACOLOGY Prednisolone acetate is a glucocorticoid that, on the basis of weight, has 3 to 5 times the anti-inflammatory potency of hydrocortisone. Glucocorticoids inhibit the edema, fibrin deposition, capillary dilation, and phagocytic migration of the acute inflammatory response, as well as capillary proliferation, deposition of collagen, and scar formation. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Uncomplicated cases of Phacoemulsification with IOL implantation. Uncomplicated being defined as
a. No capsular dehiscence
b. Placement of single piece foldable IOL in the capsular bag
c. No sutures applied
2. Includes surgeries where there have been iris handling/trauma (e.g. due to IFIS) or where iris retractors were used
3. Includes surgeries done under GA/Peri-bulbar block/Topical anaesthesia
4. Includes per-operative use of intra-cameral adrenaline and/or trypan blue
 
 
ExclusionCriteria 
Details  1. Presence of intra-ocular inflammation.
2. History of uveitis – anterior/posterior/pan.
3. Rubeosis iridis.
4. Diabetic eye disease including any diabetic retinopathy (even background).
5. History of herpes simplex/HZO (as there may be corneal anaesthesia and subsequent epithelial problems with NSAID therapy).
6. Glaucoma patients on prostaglandin analogue medication.
7. Ocular surface damage secondary to dry eye disease involving staining of the cornea. Conjunctival staining alone is not an exclusion criteria.
8. Use of per-operative intra-cameral antibiotics and/or lignocaine
9. Any intraocular procedure in the last 3 months.
10. Lost to follow up.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Anterior segment inflammation
Pain 
1,3 and 5 weeks post surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Cystiod macular oedema  1,3 and 5 weeks post surgery 
 
Target Sample Size   Total Sample Size="240"
Sample Size from India="240" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/05/2014 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not published 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Rationale and background

It is standard practice to put patients on tapering doses of topical steroids after all forms of cataract surgeries. It has been our experience that we can often switch patients to NSAID drops after a week of steroid-antibiotic drops after uncomplicated cataract surgery. This is essentially done to avoid side-effects of topical steroids like secondary glaucoma, rebound iritis etc. In our practice we have been replacing steroids with NSAIDs primarily to avoid rebound iritis in patients who had this complication in the first eye. It then dawned upon us that topical NSAIDs could have an extended role in post-cataract surgery scenario and we may be able to avoid topical steroids altogether in this context. This study is proposed to establish as evidence that modern NSAIDs may safely replace steroids one week after uncomplicated cataract surgeries.

This study is a prelude to another study which will question whether steroids are required even during the first week after clean Phacoemulsification.

Relevant data is not available for Indian population – which is also an incentive for the study.

Aims and objectives

Primary objective of the study is to answer the question: “Are steroids required to control post-operative inflammation after uncomplicated phacoemulsification surgery?”

We will also be collecting OCT data to look at preliminary evidence as to whether the incidence of CME is different between the two broad treatment groups – those with steroid followed by NSAID and those treated with steroids throughout the course of follow up.

 
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