| 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
|
|
|
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
|
|
|
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 |