| CTRI Number |
CTRI/2026/02/104644 [Registered on: 24/02/2026] Trial Registered Prospectively |
| Last Modified On: |
24/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to evaluate outcome of Cataract Surgery with KDB Goniotomy in patients with Glaucoma |
|
Scientific Title of Study
|
Outcome of Phacoemulsification with Kahook Dual Blade Goniotomy in patients with Glaucoma |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vijaya Pai H |
| Designation |
Professor and Unit Head |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Ophthalmology, Kasturba Hospital, Udupi-Hebri Road, Madhav Nagar, Manipal, Karnataka – 576104
Udupi KARNATAKA 576104 India |
| Phone |
919845426427 |
| Fax |
|
| Email |
pai.vijaya@manipal.edu |
|
Details of Contact Person Scientific Query
|
| Name |
Rutvi Yogesh Doshi |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Ophthalmology, Kasturba Hospital, Udupi-Hebri Road, Madhav Nagar, Manipal, Karnataka – 576104
Udupi KARNATAKA 576105 India |
| Phone |
918879042911 |
| Fax |
|
| Email |
doshi.kmcmpl2024@learner.manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
Rutvi Yogesh Doshi |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Ophthalmology, Kasturba Hospital, Udupi-Hebri Road, Madhav Nagar, Manipal, Karnataka – 576104
Udupi KARNATAKA 576104 India |
| Phone |
918879042911 |
| Fax |
|
| Email |
doshi.kmcmpl2024@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Rutvi Yogesh Doshi |
| Address |
Deptartment of Ophthalmology, Kasturba Hospital, Udupi-Hebri Road, Madhav Nagar, Manipal, Karnataka – 576104
|
| 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 |
| Dr Rutvi Yogesh Doshi |
Kasturba Hospital, Manipal |
Department of Ophthalmology, Kasturba Hospital, Udupi-Hebri Road, Madhav Nagar, Manipal, Karnataka – 576104
Udupi KARNATAKA |
8879042911
doshi.kmcmpl2024@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research) |
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 |
40.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed with primary open-angle glaucoma, pseudoexfoliation glaucoma, pigmentary glaucoma, normal tension glaucoma, traumatic glaucoma and combined mechanism glaucoma
2. Underwent Phacoemulsification with intraocular lens implantation with KDB goniotomy from 1st January 2024 in Kasturba Hospital, Manipal by
a) Dr. Vijaya Pai H.
b) Dr. Neetha K.I.R.
3. Completed 6 months of follow up
|
|
| ExclusionCriteria |
| Details |
1. Past history of previous glaucoma procedures like trabeculectomy, drainage implant, cyclodestruction procedure or minimally invasive glaucoma surgery in the same eye
2. Neovascular or uveitic glaucoma
3. Incomplete records
4. Intraoperative complications requiring additional glaucoma surgery at the time of surgery
5. Underwent additional glaucoma surgery during the 6 months follow up period
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Changes in Intraocular pressure (IOP) from preoperative baseline.
2. Change in number of antiglaucoma medications. |
at 1 month and 6 months follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Success rate of surgery based on IOP control or reduction in the number of anti-glaucoma medications. |
at 1 month and 6 months follow up |
| Improvement in BCVA (best corrected visual acuity) |
at 1 month and 6 months follow up |
| Incidence of intra-operative and post-operative complications. |
Intraoperative, at 1 month and 6 months follow up |
|
|
Target Sample Size
|
Total Sample Size="78" Sample Size from India="78"
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)
|
10/03/2026 |
| 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="0" 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
|
This is a retrospective, observational study designed to evaluate the surgical outcome of combined phacoemulsification with Kahook Dual Blade (KDB) goniotomy in patients diagnosed with glaucoma. The study will be conducted in the Department of Ophthalmology, Kasturba Medical College, Manipal and will include 78 eyes of patients aged 40 years and above who underwent the combined procedure from 1st January, 2024 and who have completed a minimum follow-up of 6 months. The primary objective is to assess the change in intraocular pressure (IOP) from baseline following surgery at 1 month and 6 months postoperatively. The study will also evaluate the reduction in the number of antiglaucoma medications after surgery. Secondary outcomes include improvement in best-corrected visual acuity (BCVA), overall surgical success based on IOP control and medication reduction, and the incidence of intraoperative and postoperative complications. Data will be collected retrospectively from electronic medical records using a structured data collection proforma. Preoperative variables will include demographic details, type and severity of glaucoma, baseline IOP, BCVA, and number of antiglaucoma medications. Intraoperative details and postoperative outcomes at 1 and 6 months will be recorded. No additional intervention or patient contact will be undertaken as part of this study. Statistical analysis will be performed using appropriate descriptive and inferential methods. Changes in continuous variables such as IOP and BCVA will be analyzed using paired statistical tests, and categorical variables will be assessed using suitable comparative tests. A p-value of <0.05 will be considered statistically significant. As this is a retrospective chart review, there is no direct patient involvement or alteration of standard clinical care. Institutional Ethics Committee approval has been obtained prior to data collection, and patient confidentiality will be strictly maintained through anonymization and secure data handling. |