| CTRI Number |
CTRI/2025/12/099941 [Registered on: 29/12/2025] Trial Registered Prospectively |
| Last Modified On: |
29/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
How cataract surgery changes corneql thickness and intra ocular pressure in glaucoma patients. |
|
Scientific Title of Study
|
Prospective study of central corneal thickness,ganglion cell inner plexiform layer thickness and intraocukar pressure changes in glaucoma patients after phacoemulsification surgery |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Moyya Sruti |
| Designation |
Post graduate |
| Affiliation |
Alluri sitaramaraju institute of medical sciences |
| Address |
Room no 115,Department of ophthalmology, Alluri sitaramaraju academy of medical sciences
West Godavari
ANDHRA PRADESH
534005
India |
| Phone |
9494200389 |
| Fax |
|
| Email |
srutimoyya777@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Vivekanand |
| Designation |
Head of department, professor |
| Affiliation |
Alluri sitaramaraju institute of medical sciences |
| Address |
Room 115, Department of ophthalmology, Alluri sitaramaraju academy of medical sciences
West Godavari
ANDHRA PRADESH
534005
India |
| Phone |
8333044920 |
| Fax |
|
| Email |
vivekanandu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Moyya Sruti |
| Designation |
Post graduate |
| Affiliation |
Alluri sitaramaraju institute of medical sciences |
| Address |
Room 115, Department of ophthalmology, Alluri sitaramaraju academy of medical sciences
ANDHRA PRADESH
534005
India |
| Phone |
9494200389 |
| Fax |
|
| Email |
srutimoyya777@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Moyya Sruti |
| Address |
Room 115,Department of ophthalmology, Alluri sitaramaraju academy of medical sciences, Eluru |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Alluri sitaramaraju academy of medical sciences |
Alluri sitaramaraju academy of medical sciences, Eluru |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Moyya Sruti |
Department of ophthalmology |
Room 115, Department of ophthalmology, Alluri sitaramaraju academy of medical sciences
West Godavari
ANDHRA PRADESH |
94942 00389
srutimoyya777@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ASRAMS BHR Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H42||Glaucoma in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with primary open angle,pseudoexfoliation,normotensive glaucoma whose iop is under control with anti glaucoma medication
Age more than 50 years
Visually significant cataract warranties
phacoemulsification
Ability to provide informed consent |
|
| ExclusionCriteria |
| Details |
Corneal pathologist, prior refractive surgery or corneal scars
Need for combined cataract glaucoma surgeries
Advanced retinal diseases
History of ocular trauma or neuro ophthalmic disorders |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in ganglion cell inner plexiform layer thickness |
Post operative day 1, week 1and week 6 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
20/02/2026 |
| 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="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 examines how phacoemulsification cataract surgery affects corneal thickness, intraocular pressure, and retinal ganglion cell layer thickness in glaucoma compared to non-glaucoma patients. By tracking changes before and after surgery, it aims to determine whether postoperative corneal changes alter IOP accuracy and whether retinal layer measurements can help monitor glaucoma progression. |