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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  
NIL 
 
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  
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 
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  
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  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.

 
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