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CTRI Number  CTRI/2025/06/088701 [Registered on: 12/06/2025] Trial Registered Prospectively
Last Modified On: 06/06/2025
Post Graduate Thesis  Yes 
Type of Trial  PMS 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to compare vision changes and comfort after pterygium eye surgery using stitches versus stitch-free methods with amniotic membrane graft 
Scientific Title of Study   Comparison of post operative astigmatism and patient satisfaction following pterygium excision with amniotic membrane graft using suture versus suture less, glue less techniques - a randomized controlled 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  Nomula Sathwik Reddy  
Designation  Junior Resident 
Affiliation  AIIMS BIBINAGAR 
Address  Department of Ophthalmology,AIIMS Bibinagar, Rangapur village , Bibinagar mandal ,Yadadri Bhuvanagiri district, India 508126

Nalgonda
TELANGANA
508126
India 
Phone  8919076932  
Fax    
Email  sathwikreddy46@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr.Siddharam S janti  
Designation  Additional Professor  
Affiliation  AIIMS BIBINAGAR 
Address  Department of Ophthalmology,AIIMS Bibinagar, Rangapur village , Bibinagar mandal ,Yadadri Bhuvanagiri district, India 508126

Nalgonda
TELANGANA
508126
India 
Phone  9962171725  
Fax    
Email  drsiddharam@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr.Siddharam S Janti 
Designation  Additional Professor 
Affiliation  AIIMS BIBINAGAR 
Address  Department of Ophthalmology,AIIMS Bibinagar, Rangapur village , Bibinagar mandal ,Yadadri Bhuvanagiri district ,India 508126

Nalgonda
TELANGANA
508126
India 
Phone  9962171725  
Fax    
Email  drsiddharam@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Bibinagar, Rangapur village , Bibinagar mandal ,Yadadri Bhuvanagiri district, Telangana, India 508126 
 
Primary Sponsor  
Name  Nomula Sathwik Reddy 
Address  Room no 34,Department of Ophthalmology,AIIMS Bibinagar, Rangapur village , Bibinagar mandal ,Yadadri Bhuvanagiri district, India 508126 
Type of Sponsor  Other [self] 
 
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 
Nomula Sathwik Reddy  AIIMS BIBINAGAR  Department of Ophthalmology,AIIMS Bibinagar, Rangapur village , Bibinagar mandal ,Yadadri Bhuvanagiri district , India 508126
Nalgonda
TELANGANA 		 8919076932

sathwikreddy46@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS BBN-IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: H110||Pterygium of eye,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  amniotic membrane graft fixation with sutures   amniotic membrane graft would be fixed on the bare sclera following pterygium excision with 4-6 interrupted sutures with 8-0 vicryl 
Intervention  amniotic membrane graft fixation without sutures   AMG placed over the scleral bed and held in place with Bandage contact lens for 24 hours and removed after 24 hours post operatively to visualise the graft stability as autologous blood from the scleral surface used as natural adhesive for the graft  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Age more than 18 years
Primary pterygium
Clear cornea and no ocular surface disease 
 
ExclusionCriteria 
Details  Recurrent pterygium
History of ocular trauma or previous ocular surgery
Ocular surface disorders (e.g., dry eye and blepharitis)
Systemic conditions affecting healing (e.g uncontrolled diabetes autoimmune disorders) 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Change in astigmatism from pre-op to 1 post-op
2.patient satisfaction using validated scale
and self reported patient satisfaction using likert scale  		 postoperative day 1
1 week
1 month  
 
Secondary Outcome  
Outcome  TimePoints 
1.Surgical duration
2. postoperative complications
 		 intraoperative
postoperative day 1
1 week 
 
Target Sample Size   Total Sample Size="82"
Sample Size from India="82" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   26/06/2025 
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="25" 
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  

This study is a randomized,open-label, parallel-group, single-centre trial comparing the postoperative astigmatism and patient satisfaction following pterygium excision with amniotic membrane graft using either suture or sutureless glueless technique. A total of 82 participants undergoing primary pterygium surgery will be randomized into two groups. The primary outcome measures will include change in corneal astigmatism and patient satisfaction using a validated scale, assessed on postoperative day 1, 1 week, and 1 month. Secondary outcome measures will include surgical duration and intraoperative postoperative complications.

 
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