| CTRI Number |
CTRI/2025/12/098817 [Registered on: 10/12/2025] Trial Registered Prospectively |
| Last Modified On: |
09/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Randomised controlled trial on the efficacy(Outcome)of Kahook dual blade goniotomy assisted MIGS versus I- stent implantation(Intervention) in patients with open angle glaucoma in Indian population(Participants) |
|
Scientific Title of Study
|
Randomised controlled trial on the efficacy of Kahook dual blade goniotomy assisted MIGS versus I- stent implantation in patients with open angle glaucoma in Indian population |
| Trial Acronym |
OKAIS TRIAL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ABHAY SOLANKI |
| Designation |
POST GRADUATE RESIDENT |
| Affiliation |
Army Hospital Research and Referral |
| Address |
RZ-442 M/2 BACKSIDE FIRST FLOOR, GALI NO 24 NEW PALAM COLONY , SADH NAGAR-2 , NEW DELHI
ROOM NO. 1B , DEPARTMENT OF OPHTHALMOLOGY
ARMY HOSPITAL RESEARCH AND REFERRAL,
DELHI CANTT -110010
South West
DELHI
110045
India |
| Phone |
7066530740 |
| Fax |
|
| Email |
solankia775@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SANJAY KUMAR MISHRA |
| Designation |
PROFESSOR AND HOD |
| Affiliation |
Army hospital research and referral |
| Address |
DEPARTMENT OF OPHTHALMOLOGY, ARMY HOSPITAL RESEARCH AND REFERRAL, DELHI CANTT
South West
DELHI
110045
India |
| Phone |
9811551327 |
| Fax |
|
| Email |
sanjusonu_2000@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
ABHAY SOLANKI |
| Designation |
POST GRADUATE RESIDENT |
| Affiliation |
Army hospital research and referral |
| Address |
DEPARTMENT OF OPHTHALMOLOGY, ARMY HOSPITAL RESEARCH AND REFERRAL, DELHI CANTT
DEPARTMENT OF OPHTHALMOLOGY
ARMY HOSPITAL RESEARCH AND REFERRAL,
DELHI CANTT -110010
South West
DELHI
110045
India |
| Phone |
7066530740 |
| Fax |
|
| Email |
solankia775@gmail.com |
|
|
Source of Monetary or Material Support
|
| ARMY HOSPITAL RESEARCH AND REFERRAL, NEW DELHI, INDIA -110010 |
|
|
Primary Sponsor
|
| Name |
ABHAY SOLANKI |
| Address |
RZ-442 M/2 BACKSIDE FIRST FLOOR, GALI NO 24 NEW PALAM COLONY , SADH NAGAR-2 , NEW DELHI, 110045 |
| Type of Sponsor |
Other [Other] |
|
|
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 |
| ABHAY SOLANKI |
ARMY HOSPITAL RESEARCH AND REFERRAL |
ROOM NO. 1-B, DEPARTMENT OF OPHTHALMOLOGY,ARMY HOSPITAL RESEARCH AND REFERRAL, DELHI CANTT- 110010
South West
DELHI |
7066530740
solankia775@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee,Army Hospital research and referral, Delhi Cantt |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H00-H59||Diseases of the eye and adnexa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
I-Stent Implantation |
iStent implantation is a minimally invasive surgical procedure for treating open-angle glaucoma. The iStent is a tiny, L-shaped or screw-shaped titanium tube, considered one of the smallest medical devices implanted in the human body. The stent is inserted into the eyes natural drainage system, bypassing the trabecular meshwork to create a direct channel for fluid outflow. |
| Intervention |
KAHOOK DUAL BLADE GONIOTOMY |
Kahook Dual Blade (KDB) goniotomy is a minimally invasive surgical procedure for treating open-angle glaucoma. It uses a specialized dual-blade device to precisely excise a strip of the trabecular meshwork, the eyes primary drainage tissue. This action increases the outflow of aqueous humor, thereby lowering intraocular pressure (IOP). The procedure is often performed in conjunction with cataract surgery but can also be a standalone treatment. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
i. Diagnosis of open-angle glaucoma( mild, moderate and advanced),according
to Hodapp-Parrish-Anderson criteria,namely primary open angle glaucoma,
pseudo-exfoliation glaucoma, pigmentary glaucoma.
ii. Age greater than 40 years
iii. Baseline IOP greater than 18 mmHg and less than 30 mmHg on current glaucoma medication(s)
iv. Stable glaucoma medication regimen for at least 3 months prior to enrolment
v. Visually significant cataract (more than 6/12 or worse) eligible for concurrent
phacoemulsification. |
|
| ExclusionCriteria |
| Details |
i. Angle-closure glaucoma or secondary glaucomas (e.g., neovascular, uveitic)
ii. Previous glaucoma surgery (excluding laser trabeculoplasty)
iii. Significant ocular comorbidities (e.g., retinal detachment, macular
degeneration) that may confound IOP measurements or visual outcomes.
iv. Systemic conditions that may increase surgical risk or affect IOP (e.g., active
uveitis, uncontrolled diabetes)
v. Inability to provide informed consent or comply with study procedures. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the mean change in IOP( greater than 20 percent) from baseline to 12
months post-operatively between the KDB goniotomy group and the I-Stent
implantation group. |
0, 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the reduction in mean number of glaucoma medications(more than 1 ) used
at baseline, 1, 6 and 12 months post-operatively between the two groups. |
1,6,12 months |
| Cost effective analysis between the two interventions |
Nil |
To assess the safety profiles of both procedures by comparing the incidence
and severity of adverse events |
Nil |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
23/12/2025 |
| 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="3"
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
|
Open Angle Glaucoma, a chronic and progressive optic neuropathy, is characterised by damage to the optic nerve, leading to visual field loss and cupping of the optic disc. It represents the second leading cause of irreversible blindness globally. The economic and social impact of managing glaucoma is significant in both developed and developing nations, contributing to 8% of worldwide blindness.Intra-ocular pressure (IOP) is a key modifiable risk factor and the primary target for treatment.Topical medications have a proven record of efficacy and are used as first-line therapy at all stages of glaucoma and ocular hypertension. Though chronic medication use is generally safe, efficacy is frequently undermined by high rates of patient noncompliance which increase when multiple medications are concurrently prescribed.Medications are also associated with side effects and may exacerbate dry eye and ocular surface disease.Consequently, researchers have continually sought innovative surgical approaches for glaucoma that can reduce IOP while maintaining a favourable safety profile. These newer procedures often utilise an ab- interno approach, minimising tissue trauma and promoting faster recovery.This category of procedures is generally referred to as micro invasive or minimally invasive glaucoma surgery (MIGS). MIGS has become a less invasive option compared to traditional glaucoma surgeries, offering the potential for effective IOP reduction with enhanced safety. Two commonly performed MIGS procedures are goniotomy using the Kahook Dual Blade (KDB) and implantation of the I-Stent. KDB goniotomy involves removing the compromised trabecular meshwork to improve aqueous humor outflow, whereas the i-Stent procedure involves placing tiny stents within Schlemm’s canal to bypass the trabecular meshwork. While both KDB goniotomy and i-Stent implantation have been shown to be effective in lowering IOP, there is a lack of head-to-head comparative data, particularly regarding long-term results. This randomized controlled trial (RCT) is designed to directly compare the effectiveness of KDB goniotomy-assisted MIGS and iStent implantation in reducing IOP in Indian patients with open-angle glaucoma. The findings of this study will contribute valuable data to inform clinical practice and improve treatment strategies for this condition |