| CTRI Number |
CTRI/2012/01/002366 [Registered on: 23/01/2012] Trial Registered Retrospectively |
| Last Modified On: |
01/03/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
Public Title of Study
Modification(s)
|
no suture,no fibrin glue technique of conjunctival autograft-a novel technique for pterygium surgery |
|
Scientific Title of Study
|
cut and paste-a sutureless,glue free technique of free conjunctival autograft following pterygium excision:OUR EXPERIENCE |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Satish D Shet |
| Designation |
Assistant Professor |
| Affiliation |
Karnataka Institute of Medical Sciences |
| Address |
Dept of Ophthalmology,
Karnataka Institute of Medical Sciences,
Vidyanagar,
HUBLI
B 29/2 Heggeri Colony
old Hubli
Hubli
Dharwad
KARNATAKA
580024
India |
| Phone |
09845138970 |
| Fax |
|
| Email |
satshet@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satish D Shet |
| Designation |
Assistant Professor |
| Affiliation |
Karnataka Institute of Medical Sciences |
| Address |
Dept of Ophthalmology,
Karnataka Institute of Medical Sciences,
Vidyanagar,
HUBLI
B 29/2 Heggeri Colony
old Hubli
Hubli
Dharwad
KARNATAKA
580024
India |
| Phone |
09845138970 |
| Fax |
|
| Email |
satshet@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Satish D Shet |
| Designation |
Assistant Professor |
| Affiliation |
Karnataka Institute of Medical Sciences |
| Address |
Dept of Ophthalmology,
Karnataka Institute of Medical Sciences,
Vidyanagar,
HUBLI
B 29/2 Heggeri Colony
old Hubli
Hubli
Dharwad
KARNATAKA
580024
India |
| Phone |
09845138970 |
| Fax |
|
| Email |
satshet@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Dept of ophthalmology,KIMS,HUBLI |
|
|
Primary Sponsor
|
| Name |
Karnataka Institute of Medical Sciences |
| Address |
Dept of Ophthalmology,
KIMS,
Vidyanagar,HUBLI-580029 |
| 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 satish D shet |
Dept of ophthalmology |
karnataka Institute of Medical Sciences,
Vidyanagar ,HUBLI
Dharwad
KARNATAKA |
09845138970
satshet@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Local Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
primary pterygium, invading more than one mm onto the cornea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
surgical procedure,no drugs |
free conjunctival autograft surgical procedure without sutures, without fibrin glue over the bare sclera following pterygium excision |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
primary Pterygium ,invading >1mm over the cornea |
|
| ExclusionCriteria |
| Details |
Hypertension,Diabetes Mellitus, collagen vascular diseases |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| dislodgement of the autograft and recurrence of pterygium |
at the time of dislodgement of the autograft |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| recurrence of pterygium |
10 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/02/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
preparing to send for publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To study the effect of free conjunctival graft adherence follwing pterygium excision without sutures and fibrin glue. |