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CTRI Number  CTRI/2022/04/042105 [Registered on: 22/04/2022] Trial Registered Prospectively
Last Modified On: 21/04/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Steroid Versus Non Steroid intervention]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   POST CATARACT SURGERY WITH AND WITHOUT STEROID EYE DROPS   
Scientific Title of Study   Comparative Analysis of Single Dose Intraoperative Sub-conjunctival Depot Steroid to Routine Topical Steroids and NSAIDS in phacoemulsification 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Haripriya Aravind  
Designation  Chief Cataract and IOL Services 
Affiliation  Aravind Eye Hospital 
Address  Chief Cataract and IOL Services Room 140 First Floor Poonamallee High Road
Opposite Saveetha Dental College Noombal Poonamallee Tk
Chennai
TAMIL NADU
600077
India 
Phone  914440956100   
Fax  -  
Email  haripriya@aravind.org  
 
Details of Contact Person
Scientific Query  
Name  Dr Haripriya Aravind  
Designation  Chief Cataract and IOL Services 
Affiliation  Aravind Eye Hospital 
Address  Chief Cataract and IOL Services Room 140 First Floor Poonamallee High Road
Opposite Saveetha Dental College Noombal Poonamallee Tk
Chennai
TAMIL NADU
600077
India 
Phone  914440956100   
Fax  -  
Email  haripriya@aravind.org  
 
Details of Contact Person
Public Query  
Name  Dr Haripriya Aravind  
Designation  Chief Cataract and IOL Services 
Affiliation  Aravind Eye Hospital 
Address  Chief Cataract and IOL Services Room 140 First Floor Poonamallee High Road
Opposite Saveetha Dental College Noombal Poonamallee Tk
Chennai
TAMIL NADU
600077
India 
Phone  914440956100   
Fax  -  
Email  haripriya@aravind.org  
 
Source of Monetary or Material Support  
1) Department of Ophthalmology and Quality Kaiser Permanente Oakland California USA 2) Department of Ophthalmology Northwestern University Chicago IL USA 
 
Primary Sponsor  
Name  Aravind Eye Care System AECS  
Address  India  
Type of Sponsor  Other [Private Trust] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Haripriya Aravind  Aravind Eye Hospital  Room 140 First Floor Poonamallee High Road Opposite Saveetha Dental College Noombal Poonamallee Tk
Chennai
TAMIL NADU 		 914440956100
-
haripriya@aravind.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H251||Age-related nuclear cataract,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Subconjunctival triamcinolone acetonide given sub-conjunctively   All patients shall receive intracameral antibiotic, after the administration of sub conjunctival TA – Moxifloxacin 500 microgram in 0.1 ml at the end of surgery for a period of one month 
Intervention  Topical prednisolone and NSAID given sub-conjunctively   After performing phacoemulsification, patients shall receive intracameral antibiotic – moxifloxacin 500 microgram in 0.1 ml at the end of surgery for a period of 6 weeks 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Age 40 to 75 years
2. Patients undergoing topical phacoemulsification with monofocal foldable IOL implantation
3. Senile cataract
4. Axial length of 20.5 to 25mm
5. Staying within 100 kms from base hospital and willing for all follow up visits
 
 
ExclusionCriteria 
Details  1. Age <40 years
2. Diabetes retinopathy
3. Advanced cataract (BCVA 3/60 or less)
4. NSIV, Posterior polar, subluxated , traumatic, complicated and developmental cataract
5. Pregnant and lactating women
6. Patients with mental illness
7. Non visualization of fundus
8. CDR of 0.7 & more
9. IOP of 21 & above
10. Known case of glaucoma diagnosed based on cup disc ratio, field defects, RNFL defects or raised
IOP and on treatment for the same
11. Family history of glaucoma
12. H/O steroid responsiveness
13. On systemic steroids for asthma, rheumatoid arthritis or other illness or history of steroid use by any route in the prior 3 months
14. Corneal diseases
15. Prior incisional ocular surgery
16. Associated ocular comorbidity (ARMD, pseudo exfoliation, small pupil (5mm or less), floppy iris, corneal opacity, macular scar, epiretinal membrane, retinal detachment, uveitis, shallow anterior chamber)
17. Central macular thickness (CMT) >250 μ to rule out macular edema and pachychoroid
18. Subfoveal choroidal thickness (SFCT) >300 μ
19. Presence of pachyvessels on EDI (enhanced depth imaging) OCT
20. On alpha adrenergic blockers for benign prostatic hypertrophy
21. Any intraoperative complications (PCR , ZD , Nucleus drop, Vitreous loss, iris injury)
22. Axial length <20.5mm and > 25mm
23. Any intraoperative complications (PCR , ZD , Nucleus drop, Vitreous loss)
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Visual outcome with refractive erros
 		 12 months
 
 
Secondary Outcome  
Outcome  TimePoints 
1) Macula thickness 2) Incidence of CME 3) On additional medication for raised IOP/ glaucoma due to steroids 4) On additional medication for break through iritis   12 months
 
 
Target Sample Size   Total Sample Size="402"
Sample Size from India="402" 
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   N/A 
Date of First Enrollment (India)   02/05/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="11"
Days="30" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Cataract surgery is the most common ocular surgical procedure worldwide. Surgical outcomes have become more predictable due to the improvement in surgical techniques, instrumentation and intraocular lens (IOL) design. [1] However Postoperative inflammation & CME are the commonly encountered postoperative complications following uncomplicated cataract surgery. The conventional treatment strategy to counter postoperative inflammation has been the use of various corticosteroid formulations alone or in combination with non-steroidal anti-inflammatory drugs for 4 to 8 weeks. In general, topical therapy is associated with the well-recognized problems of patient compliance and a variable amount of physician or staff time needed for patient instruction.[2]  It is also associated with other drawback like improper instillation leading to corneal abrasions.peri-operatively during cataract surgery eliminate the need for application of postoperative steroid eye drops, which requires compliance from the patients. [6-10]Various methods of steroid delivery have been described to improve the patient’s compliance. Sub–conjunctival or sub-tenon injection of depot corticosteroids is an established method for the treatment of various inflammatory eye diseases, with a good therapeutic response and ocular tolerance. [3-5] several studies show that sub-conjunctival steroids given 
 
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