| CTRI Number |
CTRI/2020/09/028097 [Registered on: 28/09/2020] Trial Registered Prospectively |
| Last Modified On: |
15/10/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
STUDY OF EFFECT OF NEPEFENAC ON SWELLING OF CENTRAL RETINA AFTER CATARACT SURGERY. |
|
Scientific Title of Study
|
COMPARISON OF EFFECT OF 0.1% VERSUS 0.3% NEPAFENAC ON CHANGES IN MACULAR AND CHOROIDAL THICKNESS AFTER CATARACT SURGERY IN PATIENTS WITH DIABETES MELLITUS. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR DEEPIKA V |
| Designation |
RESIDENT (DNB) OPHTHALMOLOGY |
| Affiliation |
SANKARA EYE HOSPITAL, SHIVAMOGGA |
| Address |
SANKARA EYE HOSPITAL, Harakere, Thirthahalli Road
Shimoga
KARNATAKA
577202
India |
| Phone |
9566097087 |
| Fax |
|
| Email |
drdeepikarajesh9988@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MAHESHA S |
| Designation |
CMO, SR CONSULTANT CATARACT |
| Affiliation |
SANKARA EYE HOSPITAL, SHIVAMOGGA |
| Address |
SANKARA EYE HOSPITAL, Harakere, Thirthahalli Road
Shimoga
KARNATAKA
577202
India |
| Phone |
9611115608 |
| Fax |
|
| Email |
maheshbhat@sankaraeye.com |
|
Details of Contact Person
Public Query
|
| Name |
DR DEEPIKA V |
| Designation |
RESIDENT (DNB) OPHTHALMOLOGY |
| Affiliation |
SANKARA EYE HOSPITAL, SHIVAMOGGA |
| Address |
SANKARA EYE HOSPITAL, Harakere, Thirthahalli Road
Shimoga
KARNATAKA
577202
India |
| Phone |
9566097087 |
| Fax |
|
| Email |
drdeepikarajesh9988@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SANKARA EYE HOSPITAL SHIVAMOGGA |
| Address |
HARAKERE, THIRTHAHALLI ROAD, SHIVAMOGGA, KARNATAKA - 577202 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 DEEPIKA V |
SANKARA EYE HOSPITAL |
Room no 12, Department of cataract ( Opthalmology) , Harakere, Thirthahalli Road ,Shimoga, Karnataka-577202.
Shimoga
KARNATAKA |
9566097087
drdeepikarajesh9988@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE-SANKARA EYE HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H590||Disorders of the eye following cataract surgery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ADMINISTRATION OF NEPAFENAC |
SUBJECTS ARE DIVIDED INTO 2 EQUAL GROUPS. ONE GROUP IS ADMINISTERED WITH 0.1 % NEPAFENAC TID AND ANOTHER GROUP WITH 0.3% NEPAFENAC OD FOR 2 WEEKS POSTOPERATIVELY. |
| Comparator Agent |
BCVA - DISTANT AND NEAR |
VISUAL ACUITY IS ASSESSED PREOPERATIVELY AND AT FOLLOW UP IN THE 2 GROUPS AND COMPARED. |
| Comparator Agent |
OCT |
OPTICAL COHERENCE TOMOGRAPHY IS DONE TO MEASURE CENTRAL SUBFIELD MACULAR THICKNESS AND SUBFOVEAL CHOROIDAL THICKNESS PREOPERATIVELY AND POSTOPERATIVELY AT 1 WEEK, 1 MONTH AND 3 MONTHS IN THE 2 GROUPS AND COMPARED. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with type 2 diabetes mellitus undergoing cataract surgery
All patients of age ranging from 40 – 70 years
Patients with Uneventful cataract surgery with intraocular lens ( IOL) in bag
Image quality > 40
Patients who are willing for follow up.
|
|
| ExclusionCriteria |
| Details |
Patients diagnosed with
Complicated cataract
Mature cataract
Uveitic cataract
Macular edema at baseline
Glaucoma associated with cataract
Posterior capsular defect
Intraocular lens in sulcus.
Patients on treatment for macular edema in the past 3 months.
Patients on anti -glaucoma drugs.
Cases with unusual post-op inflammation.
Other retinal pathologies requiring treatment / compromising vision.
Deviation from the specified technique of surgery.
Cases requiring YAG capsulotomy within the follow up period.
Patients not willing for follow up according to fixed schedule.
Cases who require laser photocoagulation in last 3 months.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the effect of 0.1% versus 0.3% Nepafenac in changes in macular thickness after cataract surgery in diabetes patients.
|
preoperatively and postoperatively at 1 week,1 month and 3 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the effect of 0.1% versus 0.3% Nepafenac in changes in choroidal thickness after cataract surgery in diabetes patients
To compare the visual outcome following cataract surgery in diabetic patients.
|
preoperatively and postoperatively at 1 week, 1 month and 3 months. |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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
Modification(s)
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
29/09/2020 |
| 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="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Pseudophakic cystoid macular edema (PCME) is one of the common complication following catarct surgery with incidence asa high as 18%.
The emergence of OCT has provided a quick and non invasive means of diagnosis of PCME.
To prevent the production of prostaglandins and decrease the inflammatory effects, we routinely use NSAID’’s in the post operative period.
There are many studies , suggesting the effect of 0.1% nepafenac and 0.3% separately in the prevention of PCME.But there are no studies comparing 0.1% and 0.3 % nepafenac in the prevention of PCME.
Hence the purpose of my study is to compare the effect of 0.1% versus 0.3% nepafenac in the prevention of pseudophakic cystoid macular edema by measuring macular and choroidal thickness by means of OCT and assessing the visual outcome after cataract surgery in diabetic patients.
|