| CTRI Number |
CTRI/2024/12/078209 [Registered on: 17/12/2024] Trial Registered Prospectively |
| Last Modified On: |
13/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Time of intervention changes] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Which is Better? Combined or Sequential approach of Cataract Surgery and Bevacizumab for patients with both Cataract and Diabetic Macular Edema problem |
|
Scientific Title of Study
|
Comparative Study on the effectiveness of Combined Cataract Surgery with Intravitreal Bevacizumab Versus Sequential Intravitreal Bevacizumab Followed by Cataract Surgery in Diabetic Macular Edema. |
| 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 CHITRA N |
| Designation |
PG STUDENT |
| Affiliation |
REGIONAL INSTITUTE OF OPHTHALMOLOGY and GOVERNMENT OPHTHALMIC HOSPITAL |
| Address |
ROOM NO: 201 and 202,
RETINA CLINIC,
DEPARTMENT OF OPHTHALMOLOGY,
REGIONAL INSTITUTE OF OPHTHALMOLOGY AND GOVERNMENT OPHTHALMIC HOSPITAL,
RUKMANI LAKSHMIPATHI ROAD,
PUDUPET,
EGMORE,
CHENNAI.
Chennai
TAMIL NADU
600008
India |
| Phone |
9790435609 |
| Fax |
|
| Email |
chitrasivagami23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SIVAKALAI R |
| Designation |
Assistant professor/Consultant |
| Affiliation |
REGIONAL INSTITUTE OF OPHTHALMOLOGY and GOVERNMENT OPHTHALMIC HOSPITAL |
| Address |
ROOM NO: 201 and 202
RETINA CLINIC,
DEPARTMENT OF OPHTHALMOLOGY,
REGIONAL INSTITUTE OF OPHTHALMOLOGY AND GOVERNMENT OPHTHALMIC HOSPITAL,
RUKMANI LAKSHMIPATHI ROAD,
PUDUPET,
EGMORE,
CHENNAI.
Chennai
TAMIL NADU
600008
India |
| Phone |
9840365372 |
| Fax |
|
| Email |
drrskalai@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr CHITRA N |
| Designation |
PG Student |
| Affiliation |
REGIONAL INSTITUTE OF OPHTHALMOLOGY and GOVERNMENT OPHTHALMIC HOSPITAL |
| Address |
ROOM NO: 201 and 202
RETINA CLINIC,
DEPARTMENT OF OPHTHALMOLOGY,
REGIONAL INSTITUTE OF OPHTHALMOLOGY AND GOVERNMENT OPHTHALMIC HOSPITAL,
RUKMANI LAKSHMIPATHI ROAD,
PUDUPET,
EGMORE,
CHENNAI.
Chennai
TAMIL NADU
600008
India |
| Phone |
9790435609 |
| Fax |
|
| Email |
chitrasivagami23@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF OPHTHALMOLOGY,
REGIONAL INSTITUTE OF OPHTHALMOLOGY AND GOVERNMENT OPHTHALMIC HOSPITAL,
RUKMANI LAKSHMIPATHI ROAD,
PUDUPET,
EGMORE,
CHENNAI. |
|
|
Primary Sponsor
|
| Name |
DEPARTMENT OF OPHTHALMOLOGY REGIONAL INSTITUTE OF OPHTHALMOLOGY AND GOVERNMENT OPHTHALMIC HOSPITAL |
| Address |
REGIONAL INSTITUTE OF OPHTHALMOLOGY AND GOVERNMENT OPHTHALMIC HOSPITAL,
RUKMANI LAKSHMIPATHI ROAD,
PUDUPET,
EGMORE,
CHENNAI. |
| Type of Sponsor |
Government medical college |
|
|
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 CHITRA N |
REGIONAL INSTITUTE OF OPHTHALMOLOGY AND GOVERNMENT OPHTHALMIC HOSPITAL |
ROOM NO: 201 and 202
RETINA CLINIC,
DEPARTMENT OF OPHTHALMOLOGY,
REGIONAL INSTITUTE OF OPHTHALMOLOGY AND GOVERNMENT OPHTHALMIC HOSPITAL,
RUKMANI LAKSHMIPATHI ROAD,
PUDUPET,
EGMORE,
CHENNAI.
Chennai
TAMIL NADU |
9790435609
chitrasivagami23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H00-H59||Diseases of the eye and adnexa, (2) ICD-10 Condition: H36||Retinal disorders in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intravitreal Injection Bevacizumab |
Drug : Bevacizumab(Anti VEGF);
Dose : 1.25 mg in 0.05 ml;
Route of administration: Intravitreal injection ;
Frequency: 1 injection ;
Follow op period: 6 months;
Method : Patients with both Cataract and Diabetic Macular Edema selected, divided into 2 groups, one group (interventional arm) will undergo cataract surgery along with Intravitreal Bevacizumab in single sitting , another group (comparator arm) first receive Intravitreal Bevacizumab then after 15 days Cataract surgery will be performed. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Diabetic patients with immature cataract
with varying levels of diabetic Retinopathy
with Diabetic macular edema
with or without treated with Pan Retinal Photocoagulation in the past
Visual Acuity less than (6/18) |
|
| ExclusionCriteria |
| Details |
Catarct due to other causes such as traumatic , developmental, complicated cataract
Advanced Diabetic Eye Disease , Vitreous Haemorrhage, Tractional membranes,
History of ocular trauma
Prior or concomitant surgery such as vitreoretinal surgery , glaucoma surgery in the operated eye, intraoperative complications.
History of Uveitis, Presence of any retinal or choroidal disease(such as Retinal Vein Occlusion, Ocular Ischemic Syndrome, and Age related Macular Degeneration) , systemic conditions other than diabetes, that could affect retinal thickness . |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in Macula using SD – OCT both Qualitative (central macular thickness ) and Quantitatively. |
within 1 week preoperative period,post operatively 14 days, 1 month, 3 month and 6 month. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Visual Acuity using Snellens chart. |
1 day, 7 days, 14 days, 30 days, then monthly for 6 months after surgery. |
|
|
Target Sample Size
|
Total Sample Size="27"
Sample Size from India="27"
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 2 |
|
Date of First Enrollment (India)
|
27/12/2024 |
| 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
|
Treatment for Diabetic Macular Edema is intravitreal injection Anti VEGF. Patients with Diabetic Macular Edema and visually significant cataract are selected.divided into 2 Groups.Group 1 patients treated with combined cataract surgery with injection Anti Bevacizumab in single sitting.Group 2 patients first treated with injection Bevacizumab then followed by cataract surgery ( sequential approach). Outcome: 1. Resolution of Macular Edema measured using OCT Macula scan .2. Visual acuity using snellen chart. To compare effect of both approaches |