| 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
|
|
|
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?â€
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.
|