| CTRI Number |
CTRI/2023/03/050650 [Registered on: 13/03/2023] Trial Registered Prospectively |
| Last Modified On: |
07/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of antiinflammatory eye drops (topical nepafenac 0.3%) on retinal thickness (central macular thickness) after cataract surgery in patients with diabetes: A randomized controlled trial
|
|
Scientific Title of Study
|
Effect of perioperative topical nepafenac 0.3% on central
macular thickness after cataract surgery in patients with diabetes: A randomized
controlled trial
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KALE SATYA GEETHIKA |
| Designation |
post graduate |
| Affiliation |
pondicherry institute of medical sciences |
| Address |
Department of ophthalmology
OPD 2 floor
pondicherry institute of medical sciences
pondicherry
605014
india
Yanam
PONDICHERRY
605014
India |
| Phone |
9790198249 |
| Fax |
|
| Email |
geethikakale94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
AMOD HANSDAK |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
pondicherry institute of medical sciences |
| Address |
Department of ophthalmology
OPD 2 floorpondicherry institute of medical sciences
pondicherry
605014
india
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9994487868 |
| Fax |
|
| Email |
amodhansdak@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
AMOD HANSDAK |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
pondicherry institute of medical sciences |
| Address |
Department of ophthalmology
OPD 2 floorpondicherry institute of medical sciences
pondicherry
605014
india
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9994487868 |
| Fax |
|
| Email |
amodhansdak@yahoo.com |
|
|
Source of Monetary or Material Support
|
| pondicherry institute of medical sciences
kalapet
puducherry
605014
india |
|
|
Primary Sponsor
|
| Name |
pondicherry institute of medical sciences |
| Address |
pondicheery institute of medical sciences
puducherry |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| kale satya geethika |
pondicherry institute of medical sciences |
Department of ophthalmology pondicherry institute of medical sciences
puducherry
605014
Pondicherry
PONDICHERRY |
9790198249
geethikakale94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIMS INSTITUTION ETHICS COMMITTEE(IEC) |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E113||Type 2 diabetes mellitus with ophthalmic complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nepafenac 0.3% eye drops
|
nepafenac 0.3% perioperatively.
once a day one drop in operated eye started one day prior before surgery and continue for 1 month in operated eye after surgery
|
| Comparator Agent |
sodium carboxymethylcellulose eye drops |
sodium carboxymethylcellulose e/d
one drop 4 times /day started oneday prior to surgery and continue for 1 month in operated eye after surgery
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All diabetic patients in the age group 40yrs and above, will be undergoing routine cataract surgery. |
|
| ExclusionCriteria |
| Details |
• Preexisting macular diseases/ macular oedema
• Recent intraocular surgery other than cataract surgery for 3 months
• Intra operative complications during the surgery
• Allergic or hypersensitive to NSAIDS, corticosteroids
• Chronic and recurrent inflammatory eye diseases.
• Use of any eye drops in last three months.
• Diseases causing macular edema other than diabetes are age related macular degeneration, Retinal venous occlusion, Coats disease, Radiation retinopathy, choroidal tumors and retinitis pigmentosa Other drugs like chloroquine, tamoxifen and interferon can induce macular edema.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the effect of perioperative nepafenac 0.3% on central macular thickness after uneventful cataract surgery in diabetes |
Follow up day 1, day-7, day 28
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the association of the effect of nepafenac (0.3%) with post cataract surgery visual acuity. |
Follow up day 1, day-7, day 28
|
|
|
Target Sample Size
|
Total Sample Size="136"
Sample Size from India="136"
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)
|
16/03/2023 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Title of the dissertation: Effect of perioperative topical nepafenac 0.3% on central macular thickness after cataract surgery in patients with diabetes: A randomized controlled trial Primary objectives: To determine the effect of perioperative nepafenac 0.3% on central macular thickness after uneventful cataract surgery in diabetes Secondary objectives: To determine the association of the effect of nepafenac (0.3%) with post cataract surgery visual acuity.
|