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CTRI Number  CTRI/2026/01/102113 [Registered on: 27/01/2026] Trial Registered Prospectively
Last Modified On: 27/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Other (Specify) 
Study Design  Single Arm Study 
Public Title of Study   Safety and Outcome of Kahook Dual Blade Eye Surgery in Patients with Open-Angle Glaucoma 
Scientific Title of Study   EFFICACY AND SAFETY OF KAHOOK DUAL BLADE GONIOTOMY IN OPEN ANGLE GLAUCOMA PATIENTS: A PROSPECTIVE STUDY 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr KOMMINENI SINDUSHA  
Designation  M.S Ophthalmology, Glaucoma fellow  
Affiliation  Nethradhama Super Speciality Eye Hospital  
Address  256/14, KANAKAPURA MAIN ROAD, JAYANAGAR 7TH BLOCK, BENGALURU, KARNATAKA Bangalore KARNATAKA 560070 India

Bangalore
KARNATAKA
560070
India 
Phone  6304343013  
Fax    
Email  sindusha1995@gmail.com   
 
Details of Contact Person
Scientific Query
 
Name  Dr KOMMINENI SINDUSHA  
Designation  M.S Ophthalmology, Glaucoma fellow  
Affiliation  Nethradhama Super Speciality Eye Hospital  
Address  256/14, KANAKAPURA MAIN ROAD, JAYANAGAR 7TH BLOCK, BENGALURU, KARNATAKA Bangalore KARNATAKA 560070 India


KARNATAKA
560070
India 
Phone  6304343013  
Fax    
Email  sindusha1995@gmail.com   
 
Details of Contact Person
Public Query
 
Name  Dr KOMMINENI SINDUSHA  
Designation  M.S Ophthalmology, Glaucoma fellow  
Affiliation  Nethradhama Super Speciality Eye Hospital  
Address  256/14, KANAKAPURA MAIN ROAD, JAYANAGAR 7TH BLOCK, BENGALURU, KARNATAKA Bangalore KARNATAKA 560070 India


KARNATAKA
560070
India 
Phone  6304343013  
Fax    
Email  sindusha1995@gmail.com   
 
Source of Monetary or Material Support  
256/14, Nethradhama Super Speciality Eye Hospital, Kanakapura main road, Jayanagar 7th block, Bengaluru Bangalore  
 
Primary Sponsor  
Name  Nethradhama Super Speciality Eye Hospital  
Address  256/14, Nethradhama Super Speciality Eye Hospital, Kanakapura main road, Jayanagar 7th block, Bengaluru Bangalore 
Type of Sponsor  Private hospital/clinic 
 
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 KOMMINENI SINDUSHA   Nethradhama Super Speciality Eye Hospital   256/14, Department of Phacorefractive surgery, Kanakapura main road, Jayanagar 7th block, Bengaluru Bangalore KARNATAKA Bangalore KARNATAKA Bangalore KARNATAKA Bangalore KARNATAKA
Bangalore
KARNATAKA 
916304343013

sindusha1995@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NETHRADHAMA SUPERSPECIALITY EYE HOSPITAL INSTITUTIONAL ETHICS COMMITTEE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H408||Other glaucoma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  1. To evaluate the IOP lowering efficacy of KDB goniotomy in open angle glaucoma patients  After obtaining informed consent from the patients enrolled in the study, baseline data including glaucoma type and severity, preoperative IOP, number of antiglaucoma medication [AGM] will be recorded. All surgeries will be performed by a single surgeon. Operative details will be noted. Patients will be followed up at 1 day, 1 week, 1, 3 and 6 months postoperatively.  
Comparator Agent  2. To evaluate the success rate and complications of KDB goniotomy in open angle glaucoma patients.  Excisional goniotomy is generally a safe procedure without significant sight-threatening complications. Transient bleeding from the TM excision site is common and typical of most angle based surgeries. The most common complications associated with excisional goniotomy are elevated intraocular pressure [3-32%], posterior capsule opacification [combined surgery][ 9%], transient pain [8%]. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients with mild to moderate stage glaucoma
Patients with a diagnosis of ocular hypertension, primary open angle glaucoma
Patients with secondary open angle glaucoma [pseudoexfoliative, pigmentary glaucoma]
 
 
ExclusionCriteria 
Details  • Patients with angle closure glaucoma
• Poor visualization of angles due to media haze
• Active uveitis
• Neovascular glaucoma
• Patients with advanced stage glaucoma
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the IOP lowering efficacy of KDB goniotomy in open angle glaucoma patients.  followed up at 1 day, 1 week, 1, 3 and 6 months postoperatively 
 
Secondary Outcome  
Outcome  TimePoints 
2. To evaluate the success rate and complications of KDB goniotomy in open angle glaucoma patients  followed up at 1 day, 1 week, 1, 3 and 6 months postoperatively 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   12/02/2026 
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="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  

 

SURGICAL TECHNIQUE

The KDB tip enters the anterior chamber through a temporal peripheral clear corneal incision and advanced to the nasal TM under direct gonioscopic visualization. The instrument’s sharp tip then engages TM, fashioning an opening through which heel at the base of footplate is seated in schlemm’s canal. Then, the tip is advanced within the canal along with TM, which is elevated onto the ramp and stretched as it is guided to two cutting blades that remove an intact TM strip. The strip is removed from the eye with KDB or with forceps. This elevation and stretching of the TM before excision maximizes the width of excised strip and protects adjacent structures from collateral injury.

STUDY POPULATION: Patients diagnosed with mild to moderate stage open angle glaucoma undergoing KDB goniotomy as a standalone or combined with phacoemulsification visiting the Glaucoma department of Nethradhama Super speciality Eye Hospital, Jayanagar, Karnataka willing to participate in the study.

 METHODOLOGY

The study will be conducted after approval by the institutional review board of Nethradhama Superspeciality Eye Hospital, Bangalore and will adhere to the tenets of declaration of Helsinki.

Procedure:

After obtaining informed consent from the patients enrolled in the study, baseline data including glaucoma type and severity, preoperative IOP, number of antiglaucoma medication [AGM] will be recorded. All surgeries will be performed by a single surgeon. Operative details will be noted. Patients will be followed up at 1 day, 1 week, 1, 3 and 6 months postoperatively. Safety will be assessed in terms of complications of the procedure. Success criteria are defined based on 20% IOP reduction or >/= 1 AGM reduction.

Excisional goniotomy is generally a safe procedure without significant sight-threatening complications. Transient bleeding from the TM excision site is common and typical of most angle based surgeries. The most common complications associated with excisional goniotomy are elevated intraocular pressure [3-32%], posterior capsule opacification [combined surgery][ 9%], transient pain [8%].

Unlike other glaucoma procedures, it does not require the implantation of a device, obviating secondary surgical procedures for device-related complications, and does not create a bleb, precluding the need for suture lysis, needling, and other postoperative bleb management procedures. Reoperation rate due to surgical failure is 2-22%, higher rates in patients with more severe glaucoma and/or higher baseline IOP.


 
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