| CTRI Number |
CTRI/2024/06/069248 [Registered on: 19/06/2024] Trial Registered Prospectively |
| Last Modified On: |
06/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective study |
| Study Design |
Other |
|
Public Title of Study
|
Outcome of correction of refractive error due to abnormal curvature of the eye by implanting special intraocular toric lens during cataract surgery |
|
Scientific Title of Study
|
Outcome of astigmatic correction with Toric Intraocular lens, an observational 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 Vijaya Pai H |
| Designation |
Professor and Head of Unit |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Ophthalmology, Kasturba Medical College, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845426427 |
| Fax |
|
| Email |
pai.vijaya@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Vijaya Pai H |
| Designation |
Professor and Head of Unit |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Ophthalmology, Kasturba Medical College, Manipal, Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
9845426427 |
| Fax |
|
| Email |
pai.vijaya@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijaya Pai H |
| Designation |
Professor and Head of Unit |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Ophthalmology, Kasturba Medical College, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845426427 |
| Fax |
|
| Email |
pai.vijaya@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Ophthalmology, Kasturba Medical College, Manipal, Karnataka, India
Pincode- 576104 |
|
|
Primary Sponsor
|
| Name |
Department of Ophthalmology Kasturba Medical College Manipal |
| Address |
OPD No- 25, Kasturba Medical College, Madhav Nagar, Manipal, Karnataka, India
Pincode- 576104 |
| Type of Sponsor |
Private medical college |
|
|
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 Vijaya Pai H |
Department of Ophthalmology, Kasturba Medical College, Manipal |
OPD no 25, Department of Ophthalmology, Kasturba Medical College, Manipal, Karnataka
Pincode- 576104
Udupi
KARNATAKA |
9845426427
pai.vijaya@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee- Student Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H25||Age-related cataract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria: Patients who underwent phacoemulsification with Toric IOL implantation in Kasturba Hospital, Manipal from 1stJanuary,2015 –30th September 2025
Surgeons-
1. Dr. Vijaya Pai H
2. Dr. Sulatha V Bhandary |
|
| ExclusionCriteria |
| Details |
1. Patients for whom post operative data is not available.
2. Retina or corneal disease, previous corneal or intraocular surgery ( except cataract) and pupil alteration. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The uncorrected visual acuity (UCVA), best corrected visual acuity (BCVA),
residual corneal astigmatism and refractive residual cylinders, 6 weeks after cataract surgery, will be measured. |
6 weeks post op |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="41"
Sample Size from India="41"
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)
|
01/08/2024 |
| 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="1"
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
|
|
Brief Summary
|
- Permission to access the records in the medical records department will be taken from The Medical Superintendent.
- We will retrospectively review the medical records of patients who had undergone phacoemulsification and implantation of a Toric intraocular lens in Kasturba Hospital, Manipal from 1st January,2015 –30th September 2025
- Surgeons- 1. Dr. Vijaya Pai H, 2. Dr. Sulatha V Bhandary
- Pre- operatively the IOL power calculation, the axial length and curvature of corneal anterior surface were measured using the IOLMaster500 (Carl Zeiss). Using the designated manufacturer’s online calculator program, the IOL cylinder power and alignment axis were calculated. The surgically induced astigmatism (SIA) was kept according to the surgeon.
- The uncorrected visual acuity (UCVA), best corrected visual acuity (BCVA),residual corneal astigmatism and refractive residual cylinders will be measured 6 week after the cataract surgery.
- We will only review the records from the medical records department who fit the inclusion criteria and no active intervention will be done.
- Potential risks and benefits: There is less than minimal risk in our study.
- Benefits: Accurate measurement of parameters and the proper method of calculation reduce the postoperative residual astigmatism after toric IOL implantation. Toric IOL implantation is safe,effective, predictable, and precise method to correct pre-existing corneal astigmatism and cataract. There is increasing emphasis on optimising refractive outcomes to decrease post-operative dependency on spectacles. Through this study we want to evaluate the refractive and visual outcomes in our patients who underwent cataract surgery with toric iol implantation and also to assess the changes in refractive and visual outcomes if any additional procedure was done (kahook dual blade goniectomy or capsule tension ring insertion) along withphacoemulsification with the toric iol implantation.
|