| CTRI Number |
CTRI/2025/09/094844 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
15/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Efficacy OF GATT surgery in Open Angle Glaucoma |
|
Scientific Title of Study
|
Efficacy of Gonioscopy-Assisted Transluminal Trabeculotomy in Open Angle Galucoma |
| 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 Nitin Gaba |
| Designation |
Post graduate Resident |
| Affiliation |
Maulana Azad medical College |
| Address |
Maulana Azad medical College, Guru Nanak eye Centre Galucoma clinic Room No 202 ,Maharaja Ranjit Singh Marg, New Delhi, Delhi 110002
Central
DELHI
110002
India |
| Phone |
7009031043 |
| Fax |
|
| Email |
gabanitin446@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Annu Joon |
| Designation |
Assistant Professor |
| Affiliation |
Maulana Azad medical College |
| Address |
Maulana Azad medical College, Guru Nanak eye Centre,Galucoma Clinic Room No 202, Maharaja Ranjit Singh Marg, New Delhi, Delhi 110002
Central
DELHI
110002
India |
| Phone |
7011255026 |
| Fax |
|
| Email |
drannujoon@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Annu Joon |
| Designation |
Assistant Professor |
| Affiliation |
Maulana Azad medical College |
| Address |
Maulana Azad medical College, Guru Nanak eye Centre, Glaucoma Clinic room No 202, Maharaja Ranjit Singh Marg, New Delhi, Delhi 110002
Central
DELHI
110002
India |
| Phone |
7011255026 |
| Fax |
|
| Email |
drannujoon@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad medical College, Bahadur Shah Zafar Marg, Near Delhi Gate, Balmiki Basti,, New Delhi, Delhi, 110002, India . |
|
|
Primary Sponsor
|
| Name |
Maulana Azad medical College |
| Address |
Maulana Azad medical College, Bahadur Shah Zafar Marg near Delhi Gate, Balmiki Basti, New Delhi, Delhi 110002 |
| Type of Sponsor |
Government medical college |
|
|
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 Nitin gaba |
Guru Nanak eye center |
Guru Nanak eye Centre, Galucoma Clinic Room No 202, Maharaja Ranjit Singh Marg, New Delhi, Delhi, 110002
New Delhi
DELHI |
7009031043
gabanitin446@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, maulana Azad medical College and associated hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H40||Glaucoma, (2) ICD-10 Condition: H401||Open-angle glaucoma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Gonioscopy-Assisted Transluminal Trabeculotomy or GATT |
For the GATT procedure, a 5-0 Prolene suture will be thermally blunted using a lowtemperature cautery. The blunted 5-0 prolene suture will be introduced through the tangential paracentesis and gently guided into the schlemm’s canal through the goniotomy using a 25gauge microsurgical forceps. The suture will be gently threaded along the circumference of the Schlemm’s canal until the distal tip emerges through the goniotomy site and the suture is then externalized and pulled, thereby completing 360° trabeculotomy. After GATT the duration of follow up with patients will be up to 4 months post intervention to look for parameters defining my primary and secondary outcome. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Moderate to advanced open angle glaucoma. Pseudoexfoliation andpigmentary glaucoma (moderate to severe). Patients with visually significant cataract requiring cataract surgery whose visual acuity is less then or equal to 6/12. Pseudophakic patients with more than 3 months history of cataract surgery. |
|
| ExclusionCriteria |
| Details |
1.Mono-ocular patients or one eyed patients.
2. Patient with history of ocular trauma or previous ocular surgery, other than cataract surgery.
3. Patience on anticoagulants.
4. Patients who have corneal pathology or previous corneal refractive Surgery, which will affect the visualisation of angle on gonioscopy and IOP measurement. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Number of eyes with complete success of GATT in OAG [defined as IOP less then 18 mmHg or 20% reduction without anti-glaucoma medication (AGM)] |
3 Months, 4Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the Number of eyes with qualified success of GATT in OAG (defined as IOP less than 18 mmHg or 20% reduction with use of AGM) at 3 months and 4 months. Mean IOP change/reduction post operatively at 3 months and 4 months. Mean change/reduction in the number of anti-glaucoma medications at 3 months and 4 months. |
3 months and 4 months |
|
|
Target Sample Size
|
Total Sample Size="23"
Sample Size from India="23"
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)
|
30/09/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Gonioscopy assisted transluminal trabeculotomy (GATT) is a type of minimally invasive glaucoma surgery. In this study patients will be recruited as per inclusion criteria. Those patient needing cataract surgery will under go combined phacoemulsification with GATT and those not requiring cataract surgery will undergo GATT alone. After the surgery patients will follow up till 4 months and see if there’s any, change in IOP, number of anti-glaucoma medication, mean deviation in visual field HVF 24-2, central corneal thickness, fundus examination and complications post operative if any, at different time periods post operative. All the data collected will be evaluated to check for primary and secondary outcome. This study will provide us sufficient data to evaluate the efficacy of GATT. |