| CTRI Number |
CTRI/2024/11/077120 [Registered on: 20/11/2024] Trial Registered Prospectively |
| Last Modified On: |
05/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Hospital Based Prospective Observational Study |
| Study Design |
Other |
|
Public Title of Study
|
MORPHOLOGICAL ASSESSMENT OF BLEBS AFTER GLAUCOMA SURGERY WITH AS OCT AND CORRELATION TO INTRAOCULAR PRESSURE |
|
Scientific Title of Study
|
Morphological Assessment Of Functioning Filtering Blebs With AS OCT and Correlation To IOP |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NEETHA P |
| Designation |
Fellow In Glaucoma |
| Affiliation |
SANKARA EYE HOSPITAL, GUNTUR |
| Address |
Room no. 132, Department of Glaucoma,
Sankara Eye Hopsital, Pedakakani, GUNTUR
Room no. 132, Department of Glaucoma,
Sankara Eye Hopsital, Pedakakani, GUNTUR
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9110601946 |
| Fax |
|
| Email |
dr.p.neetha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
NEETHA P |
| Designation |
FELLOW IN GLAUCOMA |
| Affiliation |
SANKARA EYE HOSPITAL, GUNTUR |
| Address |
Room no. 132, Department of Glaucoma,
Sankara Eye Hopsital, Pedakakani, GUNTUR
Room no. 132, Department of Glaucoma,
Sankara Eye Hopsital, Pedakakani, GUNTUR
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9110601946 |
| Fax |
|
| Email |
dr.p.neetha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
NEETHA P |
| Designation |
FELLOW IN GLAUCOMA |
| Affiliation |
SANKARA EYE HOSPITAL, GUNTUR |
| Address |
Room no. 132, Department of Glaucoma,
Sankara Eye Hopsital, Pedakakani, GUNTUR
Room no. 132, Department of Glaucoma,
Sankara Eye Hopsital, Pedakakani, GUNTUR
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9110601946 |
| Fax |
|
| Email |
dr.p.neetha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sankara Eye Hospital, GUNTUR |
|
|
Primary Sponsor
|
| Name |
DR NEETHA P |
| Address |
Sankara Eye Hospital, PEDDAKAKANI, GUNTUR |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DR NEETHA |
Sankara Eye Hospital, Guntur |
Room no. 132, Department of Glaucoma
Guntur
ANDHRA PRADESH |
9110601946
dr.p.neetha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sankara Eye Hospital, 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 |
Morphological Assessment Of Functioning Filtering Blebs With AS OCT and Correlation To IOP |
Nil |
| Comparator Agent |
Morphological Assessment Of Functioning Filtering Blebs With AS OCT and Correlation To IOP |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All patients older than 18 yrs posted for trabeculectomy and trabeculectomy with IOL surgery |
|
| ExclusionCriteria |
| Details |
1. PATIENTS WITH ORBIT, CORNEAL, OR OCULAR DISEASE THAT COULD AFFECT THE IOP
2. PATIENTS NOT REGULAR WITH FOLLOW UPS AND LIKELY TO BE LOST TO FOLLOWUP |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correlation of IOP to bleb morphology |
2 weeks, 1 month, 2 months, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Data which provides information on need for intervention |
2 weeks, 1 month, 2 months, 6 months |
|
|
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)
|
31/12/2024 |
| 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)
|
Open to Recruitment |
| 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
|
Correlation of bleb morphology parameters to IOP in post trabeculectomy patients, at 2 weeks, 1, 2, 6 months post operative period |