| CTRI Number |
CTRI/2014/12/005279 [Registered on: 11/12/2014] Trial Registered Retrospectively |
| Last Modified On: |
11/12/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Preventive
Process of Care Changes |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Pterygium (eye growth/fleshy mass) surgery outcome assessment with a different technique. |
|
Scientific Title of Study
|
To Study Results of Sutureless,glueless, conjunctival autograft in cases of Pterygium in a hospital based randomised prospective study. |
| Trial Acronym |
SFGF free-CAG |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sushobhan dasgupta |
| Designation |
Assistant professor |
| Affiliation |
Sri Guru Ram Rai Institute of Medical and Health Sciences and Sri Mahant Indiresh Hospital |
| Address |
Resident B block, SGRR Institute of Medical and Health Sciences,Patel Nagar.Dehradun
Patel Nagar. Dehradun. Uttarakhand.India.
Dehradun
UTTARANCHAL
248001
India |
| Phone |
9557992400 |
| Fax |
01352720151 |
| Email |
dr_sushobhan@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Sushobhan dasgupta |
| Designation |
Assistant professor |
| Affiliation |
Sri Guru Ram Rai Institute of Medical and Health Sciences and Sri Mahant Indiresh Hospital |
| Address |
Resident B block, SGRR Institute of Medical and Health Sciences,Patel Nagar.Dehradun
Patel Nagar. Dehradun. Uttarakhand.India.
Dehradun
UTTARANCHAL
248001
India |
| Phone |
9557992400 |
| Fax |
01352720151 |
| Email |
dr_sushobhan@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Sushobhan dasgupta |
| Designation |
Assistant professor |
| Affiliation |
Sri Guru Ram Rai Institute of Medical and Health Sciences and Sri Mahant Indiresh Hospital |
| Address |
Resident B block, SGRR Institute of Medical and Health Sciences,Patel Nagar.Dehradun
Patel Nagar. Dehradun. Uttarakhand.India.
Dehradun
UTTARANCHAL
248001
India |
| Phone |
9557992400 |
| Fax |
01352720151 |
| Email |
dr_sushobhan@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| SRI GURU RAM RAI INSTITUTE OF MEDICAL AND HEALTH SCIENCES AND SRI MAHANT INDIRESH HOSPITAL, PATEL NAGAR, DEHRADUN,UTTARAKHAND,PIN-248001. |
|
|
Primary Sponsor
|
| Name |
Sri Guru Ram Rai Institute of Medical and Health Sciences and Sri Mahant Indiresh Hospital |
| Address |
Patel Nagar. Dehradun. Uttarakhand. Pin- 248001 |
| Type of Sponsor |
Private 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 |
| Sushobhan Dasgupta |
Department of Ophthalmology |
SGRR Institute of Medical and Health Sciences and Sri Mahant Indiresh Hospital. Patel Nagar
Dehradun
UTTARANCHAL |
9557992400
01352720151
dr_sushobhan@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri Guru Ram Rai Institute of Medical and Health Sciences and Sri Mahant Indiresh Hospital.Patel Nagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
confirmed cases of PTERYGIUM growth in conjunctiva, any aye involved.from 18-60 years age., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIl |
NIL |
| Intervention |
Suturefree (without suture) and Gluefree (without Fibrin glue) free-conjunctival autograft surgery. |
Suture free and Gluefree free conjunctival autograft surgery was performed in 60 eyes of 60 patients enrolled in this non-comparative study, and the final outcome was evaluated over a period of 6 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All patients who are having Pterygium (fibrovascular overgrowth of conjunctival tissue upon cornea) were enrolled in the study |
|
| ExclusionCriteria |
| Details |
active conjunctival infection or inflammation, symblepharon, past ocular surgery or trauma within last 6 months, known diabetes mallitus, known collagen vascular disease, age below18 years and age above 60 years, pregnancy, any known bleeding disorder. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| recurrence rate, graft adherence |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| intra or postoperative surgical complication, graft or drug related complication,cost of surgery, time of surgery,symptom free interval, overall satisfaction cosmesis. |
upto 6 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/06/2014 |
| 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="0"
Months="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Aim of study: To evaluate the outcome of suturefree, gluefree method of conjunctival autograft after pterygium excision. Setting/design- prospective interventional Hospital based study. We recruted 60 eyes from 60 patients who are having pterygium.Pterygium is graded, and surgical excision was performed by single surgeon followed by free conjunctival autograft was placed over the bare sclera using natural hemostasis to take place which can itself act as bioadhesive for the graft, thus avoiding the use of fibrin glue or sutures. Time and cost of surgery was assesed.Postoperatively patients were advised antibiotic (moxifloxacin 0.5%) eye drop,Steroid(loteprednol etabonate 0.5%) eye drop, and lubricant ( carboxymethylcellulose 1%)eye drop for 6 weeks.They were all atempted for follow up on day1,7,15,30,120 and 180.At all postoperative visits thorough examination was done to see any recurrence of pterygium, any gradft dislodgement/displacement,complication related to surgery or graft or drugs.All outcome measures were tabulated.Primary outcome measures were1. recurrence of pterygium.2. graft adherence. Secondary outcme measures were 1. compication 2. symptom free interval 3.cost and time of surgery 4.cosmetic outcome 5.overall satisfaction. |