| CTRI Number |
CTRI/2024/10/074867 [Registered on: 07/10/2024] Trial Registered Prospectively |
| Last Modified On: |
06/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
To study and compare the visual outcomes and stability of two presbyopia correcting toric intraocular lenses |
|
Scientific Title of Study
|
Clinical outcomes following capsulotomy versus capsular bag fixated presbyopia correcting toric intraocular lenses - A prospective comparative 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 Sri Ganesh |
| Designation |
Chief managing director |
| Affiliation |
Nethradhama Super-speciality Eye hospital |
| Address |
Nethradhama Super Speciality Eye Hospital, Phacorefractive
Department, OPD Division, Room number 202, 256/14, Kanakapura
Rd, 7th Block, Jayanagar, Bengaluru
Bangalore
KARNATAKA
560041
India |
| Phone |
9845129740 |
| Fax |
|
| Email |
phacomaverick@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Riya Chopra |
| Designation |
Phacorefractive fellow |
| Affiliation |
Nethradhama Super-speciality Eye hospital |
| Address |
Nethradhama Super Speciality Eye Hospital, Phacorefractive
Department, OPD Division, Room number 202, 256/14, Kanakapura
Rd, 7th Block, Jayanagar, Bengaluru
Bangalore
KARNATAKA
560041
India |
| Phone |
9780100894 |
| Fax |
|
| Email |
riyachopra1154@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Riya Chopra |
| Designation |
Phacorefractive fellow |
| Affiliation |
Nethradhama Super-speciality Eye hospital |
| Address |
Nethradhama Super Speciality Eye Hospital, Phacorefractive
Department, OPD Division, Room number 202, 256/14, Kanakapura
Rd, 7th Block, Jayanagar, Bengaluru
Bangalore
KARNATAKA
560041
India |
| Phone |
9780100894 |
| Fax |
|
| Email |
riyachopra1154@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nethradhama Super Speciality Eye Hospital, 256/14, Kanakapura Rd, 7th Block, Jayanagar,
Bengaluru, Karnataka 560070 INDIA |
|
|
Primary Sponsor
|
| Name |
Nethradhama Super Speciality Eye Hospital |
| Address |
Nethradhama Super Speciality Eye Hospital, Phacorefractive
Department, OPD Division, Room number 202, 256/14, Kanakapura
Rd, 7th Block, Jayanagar, Bengaluru |
| 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 Riya Chopra |
Nethradhama Super Speciality Eye Hospital |
Nethradhama Super Speciality Eye Hospital, Phacorefractive
Department, OPD Division, Room number 202, 256/14, Kanakapura
Rd, 7th Block, Jayanagar, Bengaluru
Bangalore
KARNATAKA |
9780100894
riyachopra1154@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Nethradhama Ethics Committee |
Approved |
| Nethradhama Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H259||Unspecified age-related cataract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
FEMTIS MULTIFOCAL TORIC LENS |
FEMTIS M-Plus Toric (Teleon Surgicals BV) is a single piece aspheric multifocal Toric presbyopia correcting intraocular lens made of hydro smart material. This lens has plate haptics with additional Clip-haptics for capsulotomy fixation. Post surgery duration of study will be for 12 months. |
| Comparator Agent |
PANOPTIX TRIFOCAL TORIC LENS |
The AcrySof IQ PanOptix Toric Trifocal IOL is a single piece IOL with diffractive aspheric optic made up of Acrylate /Methacrylate Copolymer. Post surgery duration of study will be for 12 months |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Bilateral Implantation (Second eye surgery within 10 +/- 4 days).
Cataractous eyes with no comorbidity.
Regular corneal topography and corneal astigmatism.
Regular corneal topography and corneal astigmatism from 0.75 D to 4.00 D.
Availability, willingness and sufficient cognitive awareness to comply with examination procedures |
|
| ExclusionCriteria |
| Details |
Active ocular disease in the operative eye, for example, chronic uveitis, proliferative diabetic retinopathy, chronic glaucoma unresponsive to medication, corneal decompensation and corneal endothelial cell insufficiency.
Subjects with any systemic disease that could increase operative risk or confound the outcome.
Pregnant or lactating or planning a pregnancy at the time of enrolment.
Any patient who is taking part in another study involving ocular surgery.
Significant irregular corneal astigmatism- Keratoconus/ post refractive surgery/ post LASIK ectasia.
Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under Mesopic/scotopic conditions). |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To analyze and compare prospectively the post-operative visual and refractive outcomes, contrast sensitivity and patient satisfaction following implantation of 2 types of presbyopia correcting toric intra ocular lenses. |
post op day 1, 1 week, 1 month, 6 months and 12 months post-operative follow-up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the axial as well as rotational stability of the study IOLs at day 1, 1 week, 1 month, 6 months and 12 months post-operative follow-up. |
post op day 1, 1 week, 1 month, 6 months and 12 months post-operative follow-up |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
18/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
18/10/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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
|
Title: Clinical outcomes following capsulotomy versus capsular bag fixated presbyopia correcting toric intraocular lenses - A prospective comparative study Aim: To study the visual and refractive outcomes of two different trifocal toric lenses along with the analysis of axial and rotational stability. Methodology: A total of 120 eyes from 60 patients were included in the study. All patients underwent bilateral Femtosecond laser assisted cataract surgery (FLACS) using LENSAR machine. Group A included 30 patients with PanOptix toric IOL type of lens implanted in the capsular bag. Group B included 30 patients with Femtis M plus toric IOL clipped to the anterior capsulotomy. Post-operative visual and refractive outcomes, contrast sensitivity and patient satisfaction were evaluated. Axial as well as rotational stability of the IOLs at day 1, day 7, 1 month, 6 months and 12 months post-operative was analysed. |