| CTRI Number |
CTRI/2024/04/064956 [Registered on: 01/04/2024] Trial Registered Prospectively |
| Last Modified On: |
28/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative study in which participants will receive NSAIDs eye drops at different intervals after cataract surgery and the visual outcome and post operative complications will be compared. |
|
Scientific Title of Study
|
To compare visual outcome, post-operative inflammation and Cystoid macular edema in Early v/s late initiation of NSAIDs |
| 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.Mithila Pravin Joshi |
| Designation |
Primary DNB Resident |
| Affiliation |
Aravind Eye Hospitals , Chennai |
| Address |
Aravind Eye Hospital,IOL department,Room no 111, Poonamalle High Road ,Noombal, Opposite Saveetha Dental college, Chennai -600077
Aravind Eye Hospitals , Poonamallee High road , Opposite Saveetha Dental College , Noombal , Chennai -600077
Chennai
TAMIL NADU
600077
India |
| Phone |
9834757320 |
| Fax |
|
| Email |
joshi.mithila@aravind.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Haripriya Aravind |
| Designation |
Chief -IOL and Cataract department, Room no.111 ,Aravind Eye hospital, Chennai |
| Affiliation |
Aravind Eye Hospital, Chennai |
| Address |
Aravind Eye Hospital, Poonamalle High Road ,Noombal ,Opposite Saveetha dental college, Chennai -600077
Chennai
TAMIL NADU
600077
India |
| Phone |
9442643561 |
| Fax |
|
| Email |
haripriya@aravind.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Haripriya Aravind |
| Designation |
Chief -IOL and Cataract Services,Room no. 111, Aravind Eye hospital, Chennai |
| Affiliation |
Aravind Eye Hospital, Chennai |
| Address |
Aravind Eye Hospital, Poonamalle High Road ,Noombal ,Opposite Saveetha dental college, Chennai -600077
Chennai
TAMIL NADU
600077
India |
| Phone |
9442643561 |
| Fax |
|
| Email |
haripriya@aravind.org |
|
|
Source of Monetary or Material Support
|
| Aravind Eye Hospital,Poonamalle high road, Noombal, Opposite Saveetha dental college , Chennai-600077, Tamil Nadu , India |
|
|
Primary Sponsor
|
| Name |
Mithila Pravin Joshi |
| Address |
Aravind Eye Hospital , Poonamalle high road , Noombal , Chennai - 600077 |
| Type of Sponsor |
Other [Self] |
|
|
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 Mithila Pravin Joshi |
Aravind Eye Hospital , Chennai |
Aravind Eye Hospital , IOL and Cataract department, Room no 111,Poonamallee high road , Noombal, Chennai-600077,India
Chennai
TAMIL NADU |
9834757320
joshi.mithila@aravind.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee , Aravind Eye Hospital , Chennai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H598||Other intraoperative and postprocedural complications and disorders of eye and adnexa, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nepafenac |
Topical Nepafenac 0.1% thrice daily for 1 month from postoperative day 1. |
| Intervention |
Nepafenac |
Topical Nepafenac 0.1% thrice daily for 1 month starting at post operative day 21. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Visually significant cataract
Uneventful phacoemulsification with IOL implantation |
|
| ExclusionCriteria |
| Details |
1)Diabetic retinopathy and other retinal pathologies
2)History of uveitis.
3)Mature, hyper mature, traumatic, complicated cataract.
4) Known or suspected hypersensitivity to Non-Steroidal Anti-Inflammatory Drugs (NSAIDS)
5) Cystoid macular edema in the fellow eye.
6) Vascular occlusive disorders.
7) Associated Macular pathologies
8)Pregnant and lactating women
9) Patients with mental illness
10)Non visualization of fundus
11) H/O steroid responsiveness
12) H/O Prostaglandin analog usage
13) Dry eye
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in visual acuity |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Reduced incidence of post operative inflammation.
2)Reduced incidence of CME on late initiation of prophylactic NSAID therapy.
|
1 year |
|
|
Target Sample Size
|
Total Sample Size="220"
Sample Size from India="220"
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 4 |
|
Date of First Enrollment (India)
|
08/04/2024 |
| 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="1"
Months="0"
Days="0" |
|
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
|
Post operative inflammation and Cystoid Macular Edema (CME) are common complications following cataract surgery. Corticosteroids and Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) are commonly used to treat them. This study aims to compare these complications after surgery with administration of the above mentioned two drugs. Patients will be divided in two groups- Group 1 will receive topical Nepafenac 0.1% thrice daily for 1 month from postoperative day 1. Group 2 will receive topical Nepafenac 0.1% thrice daily for 1 month starting 3 weeks postoperatively. All participants will receive topical Dexamethasone 0.1% 6 times a day for 1 week, 4 times a day for the next week, and then tapered 1 drop per week over the next 3 weeks from post operative day 1. Both groups will be compared to look for post operative inflammation, CME and visual acuity after the surgery.
|