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CTRI Number  CTRI/2024/05/066781 [Registered on: 06/05/2024] Trial Registered Prospectively
Last Modified On: 03/05/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of non steroidal anti-inflammatory eye drop(nepafenac) on eye(choroidal thickness) of diabetic patients without retinopathy (an end organ damage affecting eye) following cataract surgery 
Scientific Title of Study   Impact Of 0.1% nepafenac on macular and choroidal thickness after uncomplicated Phacoemulsification surgery 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anushree C M 
Designation  Senior resident 
Affiliation  Command hospital (Central Command), Lucknow 
Address  Department of Ophthalmology, Military Hospital Agra, Idgah Colony, Agra Cantt, Agra, Uttar Pradesh

Agra
UTTAR PRADESH
282001
India 
Phone    
Fax    
Email  anushreecm6@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jaya Kaushik 
Designation  Professor 
Affiliation  Command Hospital(Central command), Lucknow 
Address  Department Of Ophthalmology, Command Hospital(Central Command), Lucknow

Lucknow
UTTAR PRADESH
226002
India 
Phone  8390010094  
Fax    
Email  arnavjaya@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Jaya Kaushik 
Designation  Professor 
Affiliation  Command Hospital(Central command), Lucknow 
Address  Department Of Ophthalmology, Command Hospital(Central Command, Lucknow

Lucknow
UTTAR PRADESH
226002
India 
Phone  8390010094  
Fax    
Email  arnavjaya@gmail.com  
 
Source of Monetary or Material Support  
Command Hospital(Central Command), Sadar Bazar, Cantonment Road, Lucknow, Uttar Pradesh 226002 
 
Primary Sponsor  
Name  nil 
Address  nil 
Type of Sponsor  Other [nil] 
 
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 Anushree C M  Command Hospital(Central Command)  Department Of Ophthalmology, Command Hospital(Central Command), Lucknow Sadar Bazaar, Cantonment, Lucknow, Uttar Pradesh
Lucknow
UTTAR PRADESH 		 9742188522

anushreecm6@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC, Command Hospital(Central Command)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H309||Unspecified chorioretinal inflammation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control group  On only postoperative antibiotic steroid combination eye drops for 1 month following cataract surgery 
Intervention  Nepafenac Group  On postoperative antibiotic steroid combination eye drops along with topical nepafenac for 1 month following cataract surgery 
 
Inclusion Criteria  
Age From  55.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Diabetic patients with no clinical evidence of diabetic retinopathy who have senile immature cataract (gr 2, gr 3) scheduled to undergo cataract extraction and posterior chamber Intra-ocular lens implantation 
 
ExclusionCriteria 
Details  1. Anterior segment pathology (corneal opacities, PEX, dense cataract)
2. Posterior segment pathology (DR, ARMD, retinal vascular diseases, uveitis)
3. Intra & Postoperative complications(TASS, raised IOP)
4.History of chronic oral/topical medication, intraocular surgery, ocular trauma.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Choroidal thickness measurements at 5 points (sub-foveal, 500µm temporal, nasal, superior & inferior to fovea) measured using EDI-OCT   Choroidal thickness measurements at 5 points using EDI-OCT on preoperative day, post operative 1 week and post op 1 month 
 
Secondary Outcome  
Outcome  TimePoints 
Compare subfoveal choroidal thickness at 3 months post op with initial pre op reading   3 months 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   14/05/2024 
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="1"
Days="15" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
- The study is planned the department of Ophthalmology at our Tertiary care Hospital and due permission from the Institutional Ethics Committee and Review Board is taken.
- 55-65 year old Type 2 Diabetic patients presenting to Ophthalmology OPD requiring cataract surgery and with previous history of diabetic retinopathy will be enrolled in the study.
- A detailed history will be obtained from all patients including duration of diabetes, diabetic control and medications of diabetes mellitus. History pertaining to previous ocular trauma, ocular intervention like surgery, intravitreal injection or laser will also be obtained.
- All the patients will undergo ophthalmic examination including visual acuity assessment by Snellen’s chart, refraction & best corrected visual acuity, Anterior segment examination by Slit lamp bio-microscopy and IOP by NCT. After dilatation, a detailed central fundus evaluation with slit lamp bio-microscopy with a 90 D lens followed by peripheral fundus examination with
an indirect ophthalmoscope & 20D lens
- Accordingly as per pre set inclusion-exclusion criteria study sample is filtered.
- Simple random sampling is done by lottery method to make 2 groups. Both the groups will undergo EDI-OCT for baseline preoperative choroidal thickness and then phacoemulsification with posterior chamber intraocular lens implantation. 
- Group 1, the intervention group will receive 0.1% nepafenac drops 3times/day along with antibiotic-steroid combination eye drops in tapering doses from pre op day to post of 1 month. On the other hand group 2 i.e control group will receive antibiotic-steroid combination eye drops and artificial tear substitute as placebo for same time period as group 1.
- EDI-OCT done on 1 week & 1 month postop.
- All the EDI-OCT charts will be measured by the calipers on the inbuilt software of Zeiss SD OCT.  Choroidal thickness measurements at 5 points (sub-foveal, 500µm temporal, nasal, superior & inferior to fovea)


 
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