| 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
|
|
|
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
|
|
|
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.
|