| CTRI Number |
CTRI/2025/11/096853 [Registered on: 03/11/2025] Trial Registered Prospectively |
| Last Modified On: |
31/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Advanced scan in assessing special type of cataract that is Posterior Polar Cataract |
|
Scientific Title of Study
|
Anterior Segment Optical Coherence Tomography analysis of clinically diagnosed Posterior Polar Cataract |
| 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 Bibi Asma Rajesahab Chiraldinni |
| Designation |
Secondary DNB resident Ophthalmology |
| Affiliation |
Sankara Eye Hospital Shimoga |
| Address |
Room no.16,Department of cornea,Sankara Eye Hospital Harakere,Thirthahalli Road Shimoga Karnataka 577202
Shimoga
KARNATAKA
577202
India |
| Phone |
8847782862 |
| Fax |
|
| Email |
bibiasmac@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mallikarjun M H |
| Designation |
Senior consultant |
| Affiliation |
|
| Address |
Room no.16,Department of Cornea,Sankara Eye Hospital Harakere,Thirthahalli Road Shimoga,Karnataka 577202
Shimoga
KARNATAKA
577202
India |
| Phone |
9611878309 |
| Fax |
|
| Email |
malikrj7@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bibi Asma Rajesahab Chiraldinni |
| Designation |
Secondary DNB resident Ophthalmology |
| Affiliation |
|
| Address |
Room no.16,Department of Cornea,Sankara Eye Hospital Harakere,Thirthahalli Road,Shimoga Karnataka 57720
Shimoga
KARNATAKA
577202
India |
| Phone |
8847782862 |
| Fax |
|
| Email |
bibiasmac@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sankara Eye Hospital,Harakere,Thirthahalli Road,Shimoga,Karnataka 577202 |
|
|
Primary Sponsor
|
| Name |
Dr.Bibi Asma Rajesahab Chiraldinni |
| Address |
Sankara Eye Hospital Harakere Thirthahalli Road Shimoga Karnataka 577202 |
| 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 |
| Dr Bibi Asma Rajesahab Chiraldinni |
Sankara Eye Hospital Shimoga |
Room no.16,Department of Cornea,Harakere,Thirthahalli Road Shimoga Karnataka 577202
Shimoga
KARNATAKA |
08847782862
bibiasmac@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sankara Eye Hospital Shimoga |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H268||Other specified cataract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients of 10 years of age and onwards of both genders
2)Patients diagnosed of having Posterior Polar Cataract
3)Posterior Polar Cataract with nuclear sclerosis grade 1-2
4)Pupil dilatation greater or equal to 7 mm |
|
| ExclusionCriteria |
| Details |
1)Associated Posterior Subcapsular Cataract or Cortical Cataract
2)History of significant ocular trauma
3)Pseudoexfoliation syndrome
4)Shallow anterior chamber
5)Pre existing corneal pathology
6)Pre existing Retinal pathology |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To analyse AS OCT(Anterion) characteristics of Posterior Polar Cataract |
At presentation(baseline) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To classify Posterior Polar Cataract based on analysis |
At presentation(baseline) |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="45" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/11/2025 |
| Date of Study Completion (India) |
01/07/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
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
|
Posterior Polar Cataract is rare form of congenital Cataract.Incidence ranging from 3-5 in 1000.Bilateral in 65-80% of cases. No gender predilection patients presents with complaint of glare and reduced vision in bright light Posterior Polar Cataract is round,discoid and opaque mass consisting of malformed and distorted lens fibres located in central posterior part of lens. Anterior segment Optical Coherence Tomography uses longer wavelength (1300nm) light source,allowing deeper penetration into the anterior segment and providing high contrast images. In this study we can study posterior polar cataract based on Anterior Segment Optical Coherence Tomography images under parameter of location of lenticular opacity,density,size of lenticular opacity,adhesion of opacity to posterior capsule and intactness of posterior capsule. By doing this study we can understand whether Cataract is central or peripheral,involvement of visual axis,whether it is adherent to posterior capsule or it is separate,whether pre existing posterior capsule defect is there or not,so we can classify Posterior Polar Cataract to know high risk or low risk case and we can take proper surgical precautions to avoid complications
|