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CTRI Number  CTRI/2022/11/047163 [Registered on: 09/11/2022] Trial Registered Prospectively
Last Modified On: 31/10/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   change in refractive power before and after pterygium excision 
Scientific Title of Study   Assessment of preoperative and postoperative changes in keratometry reading and corneal astigmatism after pterygium excision with conjunctival autograft transplantation 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Tahir Husain Ansari 
Designation  Associate Professor 
Affiliation  Rohilkhand medical college and hospital 
Address  Room No.- 1069 Department of ophthalmology Rohilkhand medical college and hospital , pilibhit bypass road , Bareilly

Bareilly
UTTAR PRADESH
243006
India 
Phone  9012355563  
Fax    
Email  drtahir08@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Tahir Husain Ansari 
Designation  Associate Professor 
Affiliation  Rohilkhand medical college and hospital 
Address  Room No.- 1069 Department of ophthalmology Rohilkhand medical college and hospital , pilibhit bypass road , Bareilly

Bareilly
UTTAR PRADESH
243006
India 
Phone  9012355563  
Fax    
Email  drtahir08@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Antariksh Agrawal 
Designation  PG resident  
Affiliation  Rohilkhand medical college and hospital 
Address  Room No.- 1069 Department of ophthalmology Rohilkhand medical college and hospital , pilibhit bypass road , Bareilly

Bareilly
UTTAR PRADESH
243006
India 
Phone  6265127281  
Fax    
Email  agrawalantariksh@gmail.com  
 
Source of Monetary or Material Support  
Rohilkhand medical college and hospital 
 
Primary Sponsor  
Name  Rohilkhand medical college and hospital 
Address  Rohilkhand medical college and hospital, pilibhit bypass road , bareilly 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Tahir Husain Ansari  Rohilkhand Medical college and hospital  Room No -1069 , department of ophthalmology
Bareilly
UTTAR PRADESH 
9012355563

drtahir08@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC,RMCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H110||Pterygium of eye,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients with a primary ocular pterygium causing visual symptoms or for cosmetic reasons. 
 
ExclusionCriteria 
Details  Recurrent Pterygium
Inflamed Pterygium
Pseudo Pterygium
Previous history of Corneal disease or degeneration
Previous history of intraocular surgery or eye trauma
Systemic diseases like collagen vascular disorders 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assessment of keratometry reading and corneal astigmatism after pterygium excision with conjunctival autograft transplantation.  At post - operative day 1
At 1 month 
 
Secondary Outcome  
Outcome  TimePoints 
Determination of difference in mean corneal curvature and to find out type of corneal astigmatism  At 1 month post operatively 
 
Target Sample Size   Total Sample Size="107"
Sample Size from India="107" 
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)   15/11/2022 
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   1-Ghiasian, Leila et al. “Recurrent Pterygium: A Review”. Journal of current ophthalmology. 2022 33(4), 367-78. 2-Chevuturu, M. “Assessment of pre-operative and postoperative changes in corneal astigmatism after pterygium excision by different techniques”. Asian journal of Medical research. 2020; 9(2), 1-4. 3-Garg P, Sahai A. “A comparative study of preoperative and postoperative changes in corneal astigmatism after pterygium excision by different techniques.”Indian journal of ophthalmology. 2019;67,1036-39. 4-Shenoy D, Nazareth N. “Comparative study of Astigmatism before and after Pterygium Excision.”IOSR Journal of Dental and Medical Sciences.2019;18(8),59-62 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Pterygium is a wing shape fibrovascular degeneration of subconjunctival tissue. It destroys bowman’s membrane and corneal stroma by proliferating as vascularized granulation tissue. Ultraviolet B the main etiological factor mutates p53 tumor suppressor gene present at limbal stem cell and leads to overexpression of TGF-beta and VEGF which results in upregulation of collagenase, cellular migration and angiogenesis. Elastotic degeneration of collagen and subepithelial fibrovascular tissue are the characteristic pathological feature of the pterygium. Pterygia are thick and vascular when early but becomes pale and thin when cease to progress       and leads to formation of dense fibrous tissues and development of considerable corneal astigmatism. Pterygium exerts a tractional force on cornea, which results in flattening of corneal curvature   in horizontal meridian leading to with-the-rule astigmatism. Flattening also occurs due to pooling of tears near the head of pterygium. Most patient of pterygium complaints of foreign body sensation, lacrimation, redness, dryness and itching. Spatial contrast sensitivity and glare disability are worsened in patients even when the visual acuity is minimally affected. Cosmetic reasons, visual impairment, motility     restriction is some of the indication for pterygium surgery.

Pterygium excision is the mainstay of treatment but with high tendency to                          reoccur. The gold standard in treatment of pterygium is pterygium excision with autograft implantation which has low rate of recurrences and complication. The present study aims to evaluate keratometry readings and corneal astigmatic changes following pterygium excision with conjunctival autograft transplantation using fibrin glue. Since a few studies have been done on this aspect therefore this study has been undertaken. 

 
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