| CTRI Number |
CTRI/2025/10/096279 [Registered on: 22/10/2025] Trial Registered Prospectively |
| Last Modified On: |
04/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational |
| Study Design |
Other |
|
Public Title of Study
|
Comparing Cataract Surgery Alone versus Cataract Surgery with a minimally invasive Glaucoma Procedure in Patients with Increased Eye Pressure. |
|
Scientific Title of Study
|
Comparison of Outcomes of Phacoemulsification with MIGS versus Phacoemulsification in Primary Angle Closure Disease |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DIVYA REVATI B N |
| Designation |
SENIOR RESIDENT |
| Affiliation |
ARAVIND EYE HOSPITAL, CHENNAI |
| Address |
Room no. 208, Department of Glaucoma, Aravind Eye Hospital, Poonamallee High Road, Opposite Saveetha Dental College, Numbal, Poonamallee, Chennai
Poonamallee High Road, Opposite Saveetha Dental College, Numbal, Poonamallee, Chennai - 600077
Chennai
TAMIL NADU
600077
India |
| Phone |
8950660910 |
| Fax |
|
| Email |
divya.revathi@aravind.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neethu Mohan |
| Designation |
Head of the department & Associate Professor |
| Affiliation |
ARAVIND EYE HOSPITAL, CHENNAI |
| Address |
Room no. 208, Department of Glaucoma, Aravind Eye Hospital, Poonamallee High Road, Opposite Saveetha Dental college, Numbal, Poonamallee,Chennai
Poonamallee High Road, Opposite Saveetha Dental college, Numbal, Poonamallee,Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
9894705666 |
| Fax |
|
| Email |
neethumohan@aravind.org |
|
Details of Contact Person
Public Query
|
| Name |
DIVYA REVATI B N |
| Designation |
SENIOR RESIDENT |
| Affiliation |
ARAVIND EYE HOSPITAL, CHENNAI |
| Address |
Room no. 208, Department of Glaucoma, Aravind Eye Hospital, Poonamallee High Road, Opposite Saveetha Dental college, Numbal, Poonamallee,Chennai
Poonamallee High Road, Opposite Saveetha Dental college, Numbal, Poonamallee,Chennai - 600077
Chennai
TAMIL NADU
600077
India |
| Phone |
8950660910 |
| Fax |
|
| Email |
divya.revathi@aravind.org |
|
|
Source of Monetary or Material Support
|
| Aravind Eye Hospital, Poonamallee High Road, Opposite Saveetha Dental college, Numbal, Poonamallee,Chennai
Chennai
TAMIL NADU
600077
India |
|
|
Primary Sponsor
|
| Name |
ARAVIND EYE HOSPITAL |
| Address |
Poonamallee High Rd, opposite Saveetha Dental College, Numbal, Poonamallee, Chennai, Tamil Nadu 600077 |
| 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 Divya Revati B N |
Aravind Eye Hospital |
Room no:208, Department of Glaucoma, Poonamallee High Rd, opposite Saveetha Dental College, Numbal, Poonamallee
Chennai
TAMIL NADU |
8950660910
divya.revathi@aravind.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Aravind Eye Hospital, Chennai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H402||Primary angle-closure glaucoma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Phacoemulsification with Tanito hook micro trabeculotomy |
Standard cataract surgery by phacoemulsification is combined with ab interno microhook trabeculotomy. Using a Tanito microhook under gonioscopic view, 2–3 clock hours of trabecular meshwork and Schlemm’s canal are incised to enhance aqueous outflow. |
| Comparator Agent |
Standalone Phacoemulsification |
Conventional cataract extraction using phacoemulsification with intraocular lens implantation is performed. No additional glaucoma surgery is added, and outcomes are assessed following cataract surgery alone. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged 40 - 80 years
2. PAC and PACG of PACD spectrum with baseline IOP more than 21mm Hg on one or more AGMs
3. Gonioscopically open nasal angle Post-YAG
4. Peripheral Iridotomy
5. Patients with significant cataract
6. Willing to give informed consent and comply with follow-up.
|
|
| ExclusionCriteria |
| Details |
PACS and PAC not on AGM
Acute primary angle closure (APAC)
Advanced and severe PACG
Secondary angle closure glaucoma
Gonioscopically closed angles nasally
History of glaucoma filtering surgery
Corneal opacity
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the IOP reduction between MIGS with phacoemulsification and phacoemulsification alone in PACD spectrum.
|
Postoperative Day 1
Postoperative period 2 WEEKS
Postoperative period 1 MONTH
Postoperative period 3 MONTH
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare reduction in number of AGMs in post operative period in both groups.
2. To compare the postoperative complications in each group.
|
Postoperative Day 1
Postoperative period 2 WEEKS
Postoperative period 1 MONTH
Postoperative period 3 MONTH
|
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
03/11/2025 |
| 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="0"
Months="8"
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
|
Project Summary:
This prospective, comparative study aims to evaluate the outcomes of Phacoemulsification with Minimally Invasive Glaucoma Surgery (MIGS) versus Phacoemulsification alone in patients with Primary Angle Closure Disease (PACD). Glaucoma is the second leading cause of irreversible blindness worldwide, with PACD being particularly prevalent and severe in Asians. While phacoemulsification can effectively open the anterior chamber angle, the additional role of MIGS in enhancing intraocular pressure (IOP) control remains underexplored.
A total of 40 participants (aged 40 to 80 years) with PAC or PACG on anti-glaucoma medications and visually significant cataract will be recruited at Aravind Eye Hospital, Chennai, and assigned to two equal groups: Group A (Phaco and MIGS) and Group B (Phaco alone). The primary outcome is IOP reduction, with secondary outcomes including reduction in glaucoma medications and postoperative complications. Success is defined as more than or equal to 20% IOP reduction or reduction of at least one medication without the need for additional surgical/laser interventions.
The study will provide evidence on whether combining MIGS with phacoemulsification offers superior pressure control and reduced medication dependence, potentially improving long-term vision outcomes and quality of life in PACD patients. Ethical approval will be obtained, informed consent ensured, and participant confidentiality maintained.
This prospective, comparative study aims to evaluate the outcomes of Phacoemulsification with Minimally Invasive Glaucoma Surgery (MIGS) versus Phacoemulsification alone in patients with Primary Angle Closure Disease (PACD). Glaucoma is the second leading cause of irreversible blindness worldwide, with PACD being particularly prevalent and severe in Asians. While phacoemulsification can effectively open the anterior chamber angle, the additional role of MIGS in enhancing intraocular pressure (IOP) control remains underexplored.
A total of 40 participants (aged 40–80 years) with PAC or PACG on anti-glaucoma medications and visually significant cataract will be recruited at Aravind Eye Hospital, Chennai, and assigned to two equal groups: Group A (Phaco and MIGS) and Group B (Phaco alone). The primary outcome is IOP reduction, with secondary outcomes including reduction in glaucoma medications and postoperative complications. Success is defined as more than or equal to 20% IOP reduction or reduction of at least one medication without the need for additional surgical/laser interventions.
The study will provide evidence on whether combining MIGS with phacoemulsification offers superior pressure control and reduced medication dependence, potentially improving long-term vision outcomes and quality of life in PACD patients. Ethical approval is obtained, informed consent will be ensured, and participant confidentiality maintained. |