| CTRI Number |
CTRI/2025/11/097729 [Registered on: 20/11/2025] Trial Registered Prospectively |
| Last Modified On: |
19/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Indications and clinical outcomes of Pinhole Pupilloplasty (PPP) |
|
Scientific Title of Study
|
A Prospective Analysis of Surgical Indications and Clinical Outcomes of Pinhole Pupilloplasty (PPP) Technique |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mehul Ahlawat |
| Designation |
Postgraduate Resident |
| Affiliation |
Dr. Om Parkash Eye Institute |
| Address |
Second Floor, Room No. 05, Department of Cataract and Refractive Surgery, Dr. Om Parkash Eye Institute, 117-A, The Mall, Amritsar, Punjab
Second Floor, Room No. 05, Department of Cataract and Refractive Surgery, Dr. Om Parkash Eye Institute, 117-A, The Mall, Amritsar, Punjab
Amritsar
PUNJAB
143001
India |
| Phone |
9968900008 |
| Fax |
|
| Email |
ahlawat.mehul@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Tushya Om Parkash |
| Designation |
Cataract and Refractive Surgery Consultant |
| Affiliation |
Dr. Om Parkash Eye Institute |
| Address |
Second Floor, Room No. 05, Department of Cataract and Refractive Surgery, Dr. Om Parkash Eye Institute, 117-A, The Mall, Amritsar, Punjab
Second Floor, Room No. 05, Department of Cataract and Refractive Surgery, Dr. Om Parkash Eye Institute, 117-A, The Mall, Amritsar, Punjab
Amritsar
PUNJAB
143001
India |
| Phone |
9980813156 |
| Fax |
|
| Email |
tushya@aol.in |
|
Details of Contact Person
Public Query
|
| Name |
Tushya Om Parkash |
| Designation |
Cataract and Refractive Surgery Consultant |
| Affiliation |
Dr. Om Parkash Eye Institute |
| Address |
Second Floor, Room No. 05, Department of Cataract and Refractive Surgery, Dr. Om Parkash Eye Institute, 117-A, The Mall, Amritsar, Punjab
Second Floor, Room No. 05, Department of Cataract and Refractive Surgery, Dr. Om Parkash Eye Institute, 117-A, The Mall, Amritsar, Punjab
Amritsar
PUNJAB
143001
India |
| Phone |
9980813156 |
| Fax |
|
| Email |
tushya@aol.in |
|
|
Source of Monetary or Material Support
|
| Dr. Om Parkash Eye Institute
117-A, The Mall, Amritsar, Punjab, India , 143001 |
|
|
Primary Sponsor
|
| Name |
Mehul Ahlawat |
| Address |
Dr. Om Parkash Eye Institute, 117-A, The Mall, Amritsar, Punjab, India, 143001 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Mehul Ahlawat |
Dr. Om Parkash Eye Institute |
Second Floor, Room No. 05, Department of Cataract and Refractive Surgery, Dr. Om Parkash Eye Institute, 117-A, The Mall, Amritsar, Punjab, India, 143001
Amritsar
PUNJAB |
9968900008
ahlawat.mehul@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr Om Parkash Eye Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H186||Keratoconus, (2) ICD-10 Condition: H178||Other corneal scars and opacities, (3) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
Pinhole Pupilloplasty (PPP) |
Pinhole Pupilloplasty (PPP) will be performed under peribulbar anaesthesia using the Single-Pass Four Throw (SFT) Technique by a single surgeon. Participants will be followed up post-surgery on Post-Op Day (POD) 1, after 1 week,
1 month and 3 months.
Study will be conducted for a period of 15 months and include patient recruitment for the first 12 months and post-operative follow-up for 3 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18 to 80 years, willing to consent, with visually significant symptoms like glare, photophobia, monocular diplopia attributable to irregular corneal topography, irregular pupils, Urretes Zavalia Syndrome, and prescence of adequate iris tissue for suturing. |
|
| ExclusionCriteria |
| Details |
Age less than 18 yrs, central corneal scar or opacity, active ocular infection, pre existing glaucoma, posterior segment pathology limiting visual potential, iris atrophy, one eyes patient, unable to give consent and comply with follow up schedule. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary clinical indications for performing pinhole pupilloplasty.
To document preoperative clinical parameters and compare postoperative outcomes in terms of
a.Uncorrected and Best-corrected visual acuity
b.Contrast sensitivity
c.Strehl Ratio
d.RMS values – Total, Astigmatism, Spherical, Coma and Trefoil aberrations.
e. Subjective symptom relief using Iris Glare, Appearance and Photophobia Questionnaire.
f. Pupil centration and size.
To document intraoperative and postoperative complications. |
Baseline, Post Operative Day (POD) 1, 1 week, 1 month, 3 months. |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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)
|
01/12/2025 |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [ahlawat.mehul@gmail.com].
- For how long will this data be available start date provided 31-03-2026 and end date provided 30-06-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The objective of this study is to identify and analyze the clinical indications for performing pinhole pupilloplasty in patients with iris-related visual disturbances. Additionally, the study aims to compare both subjective and objective visual outcomes before and after surgery. Subjective assessment will be based on Iris-GAP scoring, evaluating symptoms such as glare, appearance and photophobia. Objective assessment will include measurements of visual acuity, contrast sensitivity, pupil centration and size, and a detailed wavefront analysis using parameters such as Strehl Ratio which is a metric derived from Point Spread Function (PSF), and Root Mean Square (RMS) values of Total Aberrations, Astigmatism and Higher-Order Aberrations (HOA) like Coma, Trefoil and Spherical aberrations using iTrace Wavefront Aberrometer. |