| CTRI Number |
CTRI/2024/05/067752 [Registered on: 21/05/2024] Trial Registered Prospectively |
| Last Modified On: |
10/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Comparative Study of Amniotic Membrane Graft vs Mitomycin C with Conjunctival Autograft for Primary Pterygium Treatment |
|
Scientific Title of Study
|
A Randomized Controlled Trial Comparing Efficacy of Amniotic Membrane Graft versus 0.025% Mitomycin C with Conjunctival Autograft for the treatment of Primary Pterygium
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nikita Bilania |
| Designation |
post graduate student |
| Affiliation |
Veer Chandra Singh Garhwali Government Institute of Medical Science and Research |
| Address |
Department of ophthalmology
HNB Base hospital
Srikot , srinagar Garhwal
Garhwal
UTTARANCHAL
246167
India |
| Phone |
07300829061 |
| Fax |
|
| Email |
Nikitabilania009@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Achyut Narayan Pandey |
| Designation |
Associate professor |
| Affiliation |
Veer Chandra Singh Garhwali Government Institute of Medical Science and Research |
| Address |
Department of ophthalmology
HNB Base hospital
Srikot, Srinagar Garhwal
Garhwal
UTTARANCHAL
246167
India |
| Phone |
9456792024 |
| Fax |
|
| Email |
achyutpandey@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nikita Bilania |
| Designation |
post graduate student |
| Affiliation |
Veer Chandra Singh Garhwali Government Institute of Medical Science and Research |
| Address |
Department of ophthalmology
HNB Base hospital
Srikot, Srinagar Garhwal
Garhwal
UTTARANCHAL
246167
India |
| Phone |
07300829061 |
| Fax |
|
| Email |
Nikitabilania009@gmail.com |
|
|
Source of Monetary or Material Support
|
| Veer Chandra Singh Garhwali Government Institute of Medical Science and Research |
|
|
Primary Sponsor
|
| Name |
Veer Chandra Singh Garhwali Government Institute of Medical Science and Research |
| Address |
Department of ophthalmology
HNB Base hospital
Srikot, Garhwal |
| 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 |
| NIKITA BILANIA |
HNB BASE HOSPITAL |
Room no. 61
Department of ophthalmology
Garhwal
UTTARANCHAL |
07300829061
Nikitabilania009@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee VCSGIMSR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H110||Pterygium of eye, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Amniotic Membrane Graft,
0.025% Mitomycin C with Conjunctival Autograft |
Amniotic Membrane Graft: This involves using amniotic membrane to repair the pterygium on the eyes surface.
0.025% Mitomycin C with Conjunctival Autograft: This intervention includes applying a low-concentration Mitomycin C solution and transplanting the patients own conjunctival tissue to treat the pterygium. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
a. Patients diagnosed with primary pterygium.
b. Adults (18 years and older) |
|
| ExclusionCriteria |
| Details |
a. Patients with recurrent pterygium, severe ocular conditions, such as advanced glaucoma, corneal dystrophy, or significant ocular surface disease.
b. Combined surgical procedures at the time of surgery like trabeculectomy, cataract surgery.
c. Macular degeneration or any other retinal pathology were excluded.
d. With systemic connective tissue disorders.
e. Inability to give informed consent. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Recurrence rate in conjunctival autograft with 0.02% mitomycin c versus amniotic membrane graft |
Comparison of the effectiveness will be notice at 1 week and 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Recurrence rate in conjunctival autograft with 0.02% mitomycin c versus amniotic membrane graft |
Effectiveness of recurrence after 2 months |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
01/10/2024 |
| 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
|
To see the effectiveness in patients having primary pterygium underwent Amniotic Membrane Graft versus 0.025% Mitomycin C with Conjunctival Autograft. |