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CTRI Number  CTRI/2025/09/094237 [Registered on: 04/09/2025] Trial Registered Prospectively
Last Modified On: 03/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Visualizing the eyes drainage area after Glaucoma surgery using mordern eye scans  
Scientific Title of Study   AS- OCT as a tool for assessing filtering bleb function  
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
New ID   NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr.Shraddha Lazar Arattukulam  
Designation  PG student  
Affiliation  Sankara Eye Hospital  
Address  Department of Ophthalmology, Glaucoma division ,OPD no .132, Sankara Eye hospital, Near Guntur Vijaywada highway , Pedakakani Guntur , Andhra Pradaesh, India
Sankara Eye Hospital, Near Guntur vijaywada highway , Pedakakani Guntur , Andhra Pradaesh
Guntur
ANDHRA PRADESH
522509
India 
Phone  9821126265  
Fax    
Email  shraddhalazar999@gmail.com   
 
Details of Contact Person
Scientific Query
 
Name  Dr. Malleswari Medikonda  
Designation  Consultant in Department of Glaucoma  
Affiliation  Sankara Eye Hospital  
Address  Department of Ophthalmology, Glaucoma division ,OPD no .132, Sankara Eye hospital, Newar Guntur Vijaywada highway , Pedakakani Guntur , Andhra Pradaesh, India
Near Guntur Vijaywada highway , Pedakakani Guntur , Andhra Pradaesh, India Pin code -522509
Guntur
ANDHRA PRADESH
522509
India 
Phone  9493714701  
Fax    
Email  malleswari@sankaraeye.com  
 
Details of Contact Person
Public Query
 
Name  Dr. Malleswari Medikonda  
Designation  Consultant in Department of Glaucoma  
Affiliation  Sankara Eye Hospital  
Address  Department of Ophthalmology, Glaucoma division ,OPD no .132, Sankara Eye hospital, Guntur Vijaywada highway , Pedakakani Guntur , Andhra Pradaesh, India
Near Guntur Vijaywada highway , Pedakakani Guntur , Andhra Pradaesh, India Pin code -522509
Guntur
ANDHRA PRADESH
522509
India 
Phone  9493714701  
Fax    
Email  malleswari@sankaraeye.com  
 
Source of Monetary or Material Support  
Sankara Eye Hospital, Near Guntur - Vijaywada highway , Pedakakani, Guntur , Andhra Pradaesh, India pin code - 522509 
 
Primary Sponsor  
Name  Dr Shraddha Lazar Arattukulam  
Address  Department of Ophthalmology, Glaucoma division ,OPD no .132, Sankara Eye hospital, Guntur Vijaywada highway , Pedakakani Guntur , Andhra Pradaesh, India Pin code - 522509  
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 
Shraddha Lazar Arattukulam   Sankara Eye Hospital  Department of Ophthalmology, Glaucoma division ,OPD no .132, Near Guntur Vijaywada highway , Pedakakani Pin code - 522509
Guntur
ANDHRA PRADESH 
9821126265

shraddhalazar999@gmail.com  
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee-SEH-Guntur   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H409||Unspecified glaucoma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Male and femal patients who are above 18 years of age, diagnosed as glaucoma and undergoing trabeculectomy or combined trabeculectomy and cataract surgery  
 
ExclusionCriteria 
Details  Patient with orbit , corneal or ocular diseases that could affect the IOP.
Patients not regular with follow ups and likely to be lost to follow ups. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the parameters of well functioning bleb on AS-OCT.   2 WEEKS , 1 MONTH AND 3 MONTHS  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="79"
Sample Size from India="79" 
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)   15/09/2025 
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="0"
Months="6"
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  
Glaucoma describes a group of conditions in which there is characteristics cupping of the optic disc corresponding viual feild defects due to retinal ganglion cell loss with iop being the only modifiable risk factor.
iop control after trabeculectomy depends on aqueous outflow and absorption from the bleb . The outcome depends upon a functioning filterring bleb . Hence bleb mmorphology is an important parameter to assess bleb function and predeict ble related complication .
However the major limitation of slit lamp assessment is the inability to image intrableb morphology and subjectivity of clinical grading . 
In our study we will be using ANTERION AS-OCT which shows the internal belb structure such as bleb wall refelctivity , thickness , bleb wall height , internal cavity height , internal cavity extent and trabeculectomy opening size to assess bleb morphology and to predict bleb function and assess bleb related complications.
79 patient attending the opd who are diagnosed cases of glaucoma undergoing trab or trab with iol will be assesed after fulffiling the inclusion and exclusion criteria ,written informed consent will be taken.
Patent will undergo regular glaucoma evaluvation includng gat and gonioscopy preop and will undergo bleb analysis with as -oct two scans will be taken, a radial section perpendicular to limbus through the site pf pi and a  tangential section  to the limbus through the site of maximal bleb elevation to assess the morphological characteristics of the bleb and if there is any need for early intervention  
 
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