CTRI

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CTRI Number

CTRI/2024/07/070484 [Registered on: 11/07/2024] Trial Registered Prospectively

Last Modified On:

09/07/2024

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Surgical/Anesthesia

Study Design

Single Arm Study

Public Title of Study

Outcomes of a new Implantable Collamer Lens in correcting Refractive Errors with Presbyopia

Scientific Title of Study

Visual and Refractive outcomes of a new Presbyopia correcting Implantable Collamer Lens in correcting Refractive Errors

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 Supriya Sriganesh
Designation	Executive Director
Affiliation	Nethradhama Super Speciality Eye Hospital
Address	256/14, Nethradhama Super Speciality Eye Hospital, Kanakapura main road, Jayanagar 7th phase, Bengaluru Bangalore KARNATAKA 560070 India
Phone	8951027740
Fax
Email	dr.supriyasriganesh@nethradhama.org

Details of Contact Person
Scientific Query

Name	Dr Sadhwini M H
Designation	Fellow in Phacorefractive Surgery
Affiliation	Nethradhama Super Speciality Eye Hospital
Address	256/14, Nethradhama Super Speciality Eye Hospital, Department of Phacorefractive Surgery, Kanakapura main road, Jayanagar 7th phase, Bengaluru Hassan KARNATAKA 560070 India
Phone	7795568552
Fax
Email	sadhwiniharish@gmail.com

Details of Contact Person
Public Query

Name	Dr Sadhwini M H
Designation	Fellow in Phacorefractive Surgery
Affiliation	Nethradhama Super Speciality Eye Hospital
Address	256/14, Nethradhama Super Speciality Eye Hospital, Department of Phacorefractive Surgery, Kanakapura main road, Jayanagar 7th phase, Bengaluru KARNATAKA 560070 India
Phone	7795568552
Fax
Email	sadhwiniharish@gmail.com

Source of Monetary or Material Support

Nethradhama Super Speciality Eye Hospital, Department of Phacorefractive surgery, Kanakapura main road, Jayanagar 7th phase, Bengaluru, 560070

Primary Sponsor

Name	Nethradhama Super Speciality Eye Hospital
Address	Nethradhama Super Speciality Eye Hospital, Department of Phacorefractive surgery, Kanakapura main road, Jayanagar 7th phase, Bengaluru, 560070
Type of Sponsor	Research institution and hospital

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Sadhwini M H	Nethradhama Super Speciality Eye Hospital	Nethradhama Super Speciality Eye Hospital, OPd block, 2nd floor, kanakpura main road, jayanagar 7th phase 560070 Bangalore KARNATAKA	7795568552 sadhwiniharish@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
NETHRADHAMA SUPERSPECIALITY EYE HOSPITAL INSTITUTIONAL ETHICS COMMITTEE	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: H521\|\|Myopia,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Ipmplantation of a new Presbyopic ICL	All patients aged between 45 and 55 years with Myopia and Presbyopia will undergo implantation of a new ICL and followed up postoperatively for 12 weeks
Comparator Agent	Nil	Nil

Inclusion Criteria

Age From	45.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	Myopic patients more than -4D and hyperopic patients berween +1 to +10D Best corrected Visual acuityof 20/40 or better No evidence of irregular astigmatism on corneal tomography Anterior chamber depth more than 2.8mm Endothelial cell count more than 2000 cells/mm2

ExclusionCriteria

Details

Astigmatism more than 0.5D
Progressive or unstable myopia and/or stigmatism.
Clinical or topographic evidence of keratoconus
Previous ocular surgery.
Dysfunctional lens syndrome, any evidence of cataract.
Any other active or recurrent ocular diseases.
Age related degenerations, any retinal pathology.
Corneal scars, opacities, degenarations,
Glaucoma,
Uncooperative patient

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome

TimePoints

Following tests will be performed
1.Uncorrected and Corrected distance visual acuity
2.Uncorrected and Corrected Intermediate visual acuity at 40, 60, 80cm
3.Uncorrected and Corrected near visual acuity
4.Subjective Refraction
5.Intraocular pressure
6.Slit lamp examination for clinical vault and angle
7.Vault angle and height measurements using MS-39
8.Binocular visual acuity for near and distance
9. SRD
10. HDA
11. iTrace
12. Defocus curve
13. FACT
14. Dysphotopsia questionnaire

On post-operative day 1, 2 weeks and 12 weeks

Secondary Outcome

Outcome	TimePoints
Following test will be performed 1. slit lamp photographs	On post-operative day 2 weeks

Target Sample Size

Total Sample Size="40"
Sample Size from India="40"
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 2

Date of First Enrollment (India)

20/07/2024

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="2"
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

All patients aged between 45 and 55 years will undergo implantation of a new ICL which is correcting both myopia or hypermetropia along with presbyopia. these patients are evaluated post operatively on day1, day15 and 3 months with the tests that are mentioned above.