| CTRI Number |
CTRI/2024/07/071585 [Registered on: 30/07/2024] Trial Registered Prospectively |
| Last Modified On: |
22/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Prevention of pterygium recurrence in North West Indian population by giving subpterygial injection of Mitomycin-C preoperatively as compared to intraoperative injection of Mitomycin-c |
|
Scientific Title of Study
|
Comparing Preoperative Versus Intraoperative role of Subpterygial Mitomycin C Injection in Preventing Recurrence of Pterygium reccurence in North West Indian population: A randomized Control Trial |
| 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 Sahil Jain |
| Designation |
Junior Resident |
| Affiliation |
AIIMS BATHINDA |
| Address |
Room No. 2210, Department of Ophthalmology, 2nd floor, B-Block, All India Institute of Medical Sciences Bathinda, Punjab, India -151001
Bathinda
PUNJAB
151001
India |
| Phone |
95019161514 |
| Fax |
|
| Email |
sahiljain137@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anuradha Raj |
| Designation |
Professor and Head |
| Affiliation |
AIIMS BATHINDA |
| Address |
Room No.2204 Department of Ophthalmology AIIMS Bathinda
Bathinda
PUNJAB
151001
India |
| Phone |
9897186678 |
| Fax |
|
| Email |
raj.anuradha@aiimsbathinda.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anuradha Raj |
| Designation |
Professor and Head |
| Affiliation |
AIIMS BATHINDA |
| Address |
Room No.2204 Department of Ophthalmology AIIMS Bathinda
Bathinda
PUNJAB
151001
India |
| Phone |
9897186678 |
| Fax |
|
| Email |
raj.anuradha@aiimsbathinda.edu.in |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences BATHINDA, Punjab, India - 151001 |
|
|
Primary Sponsor
|
| Name |
Dr Sahil Jain |
| Address |
Room No. 2210, Department of Ophthalmology, OPD Building, Block B, 2ND Floor, All India Institute of Medical Sciences Bathinda, Punjab, India 151001 |
| 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 Sahil Jain |
All India Institute Of Medical Sciences Bathinda |
Department of Ophthalmology , Floor 2, Block B , OPD building All India Institute Of Medical Sciences Bathinda 151001
Bathinda
PUNJAB |
95019161514
sahiljain137@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS Bathinda, Bathinda, 151001 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H110||Pterygium of eye, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intraoperative Mitomycin-c Subpterygial Injection |
Intraoperative Mitomycin-c Subpterygial Injection, 0.1 ml of 0.015 mg/ml for 1 min as single dose
Followed by Pterygium excision after 5 mins of injection with bare sclera |
| Intervention |
Preoperative Subpterygial Mitomycin-C injection |
Preoperative Subpterygial Mitomycin-C injection 0.1 ml of 0.15 mg/ml for 1 min as single dose(30 days before surgery)
Followed by pterygium excision after 30 days of injection with bare sclera |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All pterygium Patient age more than 18 years.
All those willing to give written consent to participate in study.
Primary pterygium. |
|
| ExclusionCriteria |
| Details |
1. Any Pre-existing Scleral disease or on its medication
2. Patients with anterior uveitis or anterior/posterior staphyloma
3. Any intraocular surgery or laser in recent 1 month |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To observe efficacy of preoperative subterygial mitomycin-c injection as compared to intraoperative subpterygial mitomycin-c injection in preventing pterygium recurrence |
At 3rd month of surgical excision |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate demographic & clinical characteristics of pterygium |
AT day 0 end of 1st month & 3rd month of surgical excision |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
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)
|
05/08/2024 |
| 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="6"
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
|
Pterygium recurrence is extremely common
(30–80%), making it the most common complication following surgery.
As a result, various techniques, including conjunctival autografting, intra- or
post-operative adjuvant Mitomycin-C (MMC), and amniotic membrane
transplantation, are being evaluated in an attempt to reduce this high
recurrence rate.
MMC is an alkylating agent which inhibits the
transcription of DNA into RNA. This in turn stops protein synthesis and reduces
cellular migration and proliferation. It is an antitumor antibiotic that was
isolated from Streptomyces caespitosus.
As Bathinda is at a geographical location where
weather conditions are hot, and dry during summer season the prevalence of
pterygium is high in the population of this region. Therefore, we are
conducting this study in ALL INDIA INSTITUTE OF MEDICAL SCIENCES ,BATHINDA .In
this study we will compare efficacy of bare sclera technique with 1 month prior
preoperative MMC subpterygial injection vs intra-op MMC injection with bare sclera technique. |