| CTRI Number |
CTRI/2025/10/095716 [Registered on: 08/10/2025] Trial Registered Prospectively |
| Last Modified On: |
07/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative evaluation of cataract surgery combined with glaucoma surgery with or without Microhook ab interno Trabeculotomy in Primary angle closure glaucoma
– A pilot randomized controlled trial
|
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Scientific Title of Study
|
Comparative evaluation of phacoemulsification combined with goniosynechialysis with or without Microhook ab interno Trabeculotomy in Primary angle closure glaucoma
– A pilot randomized controlled trial
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ROHAN SUNIL SONAWANE |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
AIIMS, NEW DELHI |
| Address |
Room no. 374, unit 4 office, third floor, rajendra prasad centre of ophthalmic sciences,Aiims, new delhi, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029
Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029
New Delhi
DELHI
110049
India |
| Phone |
8600398384 |
| Fax |
|
| Email |
srrohan1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DEWANG ANGMO |
| Designation |
ADDITIONAL PROFESSOR |
| Affiliation |
AIIMS, NEW DELHI |
| Address |
Room no. 374, unit 4 office, third floor, rajendra prasad centre of ophthalmic sciences,Aiims, new delhi, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029
Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029
New Delhi
DELHI
110049
India |
| Phone |
01126594127 |
| Fax |
|
| Email |
dewang45@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ROHAN SUNIL SONAWANE |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
AIIMS, NEW DELHI |
| Address |
Room no. 374, unit 4 office, third floor, rajendra prasad centre of ophthalmic sciences,Aiims, new delhi, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029
Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029
New Delhi
DELHI
110049
India |
| Phone |
8600398384 |
| Fax |
|
| Email |
srrohan1997@gmail.com |
|
|
Source of Monetary or Material Support
|
| All india insitute of medical sciences, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029 |
|
|
Primary Sponsor
|
| Name |
Dewang Angmo |
| Address |
Room no. 374, unit 4 office, third floor, rajendra prasad centre of ophthalmic sciences,Aiims, new delhi, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029 |
| Type of Sponsor |
Other [self] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Rohan Sunil Sonawane |
Dr. Rajendra Prasad Centre for Ophthalmic Sciences AIIMS, New Delhi 110029 |
Room no. 374, unit 4 office, third floor, rajendra prasad centre of ophthalmic sciences,Aiims, new delhi, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029
New Delhi
DELHI |
8600398384
srrohan1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS DELHI |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H40-H42||Glaucoma, (2) ICD-10 Condition: O||Medical and Surgical, (3) ICD-10 Condition: O||Medical and Surgical, (4) ICD-10 Condition: H402||Primary angle-closure glaucoma, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
phacoemulsification with Goniosynechialysis |
In phaco-GSL group, side port incisions (0.9 mm) with a standard temporal 2.2-mm clear corneal phaco will be done followed by implantation of a posterior chamber, foldable, single-piece hydrophobic acrylic intraocular lens (IOL) in the capsular bag. Viscoelastic will be filled in the anterior chamber, particularly the angle area. A blunt-tipped 27 G Healon cannula inserted from the main wound (temporal), and under direct gonioscopic visualization (Swan Jacob lens, University of Oregon, Portland, OR), will be used for the PAS release gently (180-270°). |
| Intervention |
phacoemulsification, goniosynechialysis, Microhook ab interno Trabeculotomy |
In Phaco-GSL + Microhook group, side port incisions (0.9 mm) with a standard temporal 2.2-mm clear corneal. Viscoelastic was filled in the anterior chamber, particularly the angle area. A blunt-tipped 27 G Healon cannula was inserted from the main wound (temporal), and under direct gonioscopic visualization (Swan Jacob lens, University of Oregon, Portland, OR), the PAS were released gently. This was followed by microlot assisted trabeculotomy in 3-4clock hrs of nasal angle. Phaco was done followed by implantation of a posterior chamber, foldable, single-piece hydrophobic acrylic intraocular lens (IOL) in the capsular bag. Use of appropriate angled microhooks; straight microhooks for nasal angles and right and left angled for temporal angles by gently ‘sliding’ the tip into the SC rather than ‘stabbing’ it in. Reaching the appropriate depth with the tip of microhook is essential, which is the major factor determining the success of procedure i.e.; how well is the Schlemm’s canal deroofed. A minimal resistance felt while probing the Schlemm’s canal indicates that the depth is adequate and there has been no inadvertent damage to inner wall of SC. Usually incising 3 clock hours of trabecular meshwork is advocated for achieving a desired IOP reduction. |
|
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Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Primary Angle Closure disease patients with cataract (who received laser peripheral iridotomy at least 8 weeks before)
Age more than or equal to 40 years
Patients willing to give consent
|
|
| ExclusionCriteria |
|
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Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the reduction in IOP in PhacoGSL+Microlot (PGM) vs PhacoGSL(PG) in PACD |
To compare the reduction in IOP in PhacoGSL+Microlot (PGM) vs PhacoGSL(PG) in PACD at baseline with
day 1, 1 week, 4 weeks, 3 months, 6 months, 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare
•Reduction in number of anti glaucoma medications
•BCVA
•Post operative complications
•Change in angle parameters on ASOCT
•Correlation of ITC with gonioscopic findings & final reduction in IOP
•compare postoperative incisional cross-sectional area & correlate with IOP reduction
•TM tissue will be sent for scanning electron microscopy analysis whenever possible.
|
at baseline with
day 1, 1 week, 4 weeks, 3 months, 6 months, 12 months |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
18/10/2025 |
| 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="3"
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
|
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Brief Summary
|
|
Primary Objective
To compare the reduction in IOP in PhacoGSL+Microlot (PGM) vs
PhacoGSL(PG) in PACD
Secondary Objectives
To compare
·
Reduction in number of anti glaucoma medications
·
BCVA
·
Post operative complications
·
Change in angle parameters on ASOCT
·
Correlation of ITC with gonioscopic findings and
final reduction in IOP
·
compare postoperative incisional cross-sectional
area and correlate with IOP reduction
·
TM tissue will be sent for scanning
electron microscopy analysis whenever possible.
|
|