| CTRI Number |
CTRI/2024/01/061667 [Registered on: 19/01/2024] Trial Registered Prospectively |
| Last Modified On: |
09/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of Effect of Laser Treatment in Patients with High Pressure in the Eye Using a Scan Machine |
|
Scientific Title of Study
|
Relationship Between Iris Thickness and Angle Opening After Laser Peripheral Iridotomy in Primary Angle Closure Disease: An AS OCT 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 Meghana Mulpuri |
| Designation |
Primary DNB Resident (Ophthalmology) |
| Affiliation |
Sankara Eye Hospital |
| Address |
Room 26, Glaucoma Department,
Sankara Eye Hospital,
Thirthahalli Road, Harakere,
Shimoga,
Karnataka
India
Shimoga
KARNATAKA
577202
India |
| Phone |
9494634422 |
| Fax |
|
| Email |
mulpuri.meghana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kamala S |
| Designation |
Senior Consultant Glaucoma |
| Affiliation |
Sankara Eye Hospital |
| Address |
Room 26, Glaucoma Department,
Sankara Eye Hospital,
Thirthahalli Road, Harakere,
Shimoga,
Karnataka
India
Shimoga
KARNATAKA
577202
India |
| Phone |
9480362192 |
| Fax |
|
| Email |
kamala13@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Meghana Mulpuri |
| Designation |
Primary DNB Resident (Ophthalmology) |
| Affiliation |
Sankara Eye Hospital |
| Address |
Room 26, Glaucoma Department,
Sankara Eye Hospital,
Thirthahalli Road, Harakere,
Shimoga,
Karnataka
India
Shimoga
KARNATAKA
577202
India |
| Phone |
9494634422 |
| Fax |
|
| Email |
mulpuri.meghana@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sankara Eye Hospital,
Thirthahalli Road, Harakere,
Shimoga,
Karnataka
India
577202 |
|
|
Primary Sponsor
|
| Name |
Sankara Eye Hospital |
| Address |
Sankara Eye Hospital,
Thirthahalli Road, Harakere,
Shimoga,
Karnataka
India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Meghana Mulpuri |
Sankara Eye Hospital |
Room 26, Glaucoma Department,
Sankara Eye Hospital,
Thirthahalli Road, Harakere,
Shimoga,
Karnataka
India
577202
Shimoga
KARNATAKA |
9494634422
mulpuri.meghana@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board of Sankara Eye Hospital |
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 |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Confirmed diagnosis of Primary Angle Closure Disease based on clinical evaluation and diagnostic tests.
2. Willing and able to provide informed consent for AS OCT imaging.
3. Ability to cooperate with imaging procedure AS OCT. |
|
| ExclusionCriteria |
| Details |
1. Patients with secondary cause of angle closure.
2. Patients requiring peripheral iridotomy augmentation.
3. Patients with plateau iris syndrome.
4. History of previous angle surgery or laser treatment.
5. Presence of corneal abnormalities that may interfere with the AS OCT imaging.
6. Eyes with incomplete laser peripheral iridotomy perforation.
7. Use of topical or systemic medications that could affect the anterior chamber.
8. History of ocular trauma or surgery within the past 6 months.
9. Pregnancy or breastfeeding in female participants. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To correlate variations in iris thickness with variations in angle opening post iridotomy.
2. To assess the impact of baseline iris morphology on post iridotomy outcomes. |
1. By comparing the iris thickness at various distances to angle opening distance and trabecular iris angle at pre-treatment, post one week and post 6 months of treatment.
2. To compare the pre-treatment iris thickness at various distance to the angle opening distance and trabecular iris angle at one week and six months post treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To analyse the effect of angle opening after iridotomy at the end of 6 months |
6 months |
|
|
Target Sample Size
|
Total Sample Size="114"
Sample Size from India="114"
Final Enrollment numbers achieved (Total)= "59"
Final Enrollment numbers achieved (India)="59" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
29/01/2024 |
| Date of Study Completion (India) |
01/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This study is an observational, single arm, follow up study investigating the relationship between iris thickness and angle opening following laser peripheral iridotomy in patients diagnosed with primary angle closure disease using Anterior Segment Optical Coherence Tomography. The primary objectives are to correlate the variations in iris thickness with variations in angle opening post iridotomy, and to assess the impact of baseline iris morphology on post iridotomy outcomes. These will be assessed at follow ups of one week and six months after the advised procedure of laser iridotomy. The secondary objective is to analyse the effect and amount of angle opening after iridotomy at the end of six months. |