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Trifocal Diffractive Intraocular Lens After Cataract Extraction With Phacoemulsification

Primary Purpose

Refractive Errors

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Trifocal diffractive intraocular lens
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractive Errors

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patient eyes had cataract with no other pathology, patients desire for spectacle independence after surgery and with realistic expectation.

Exclusion Criteria:

  • Any ocular comorbidity that affect the end results of the surgery, history of ocular trauma, irregular corneal astigmatism, pupil abnormalities and capsular or zonular abnormalities that may affect postoperative centration as tilt of the lens (e.g. pseudo exfoliation syndrome and Marfan's syndrome).

Sites / Locations

  • Alexandria Faculty of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Trifocal Diffractive Intraocular Lens (FineVision)

Arm Description

36 eyes having implantation of trifocal diffractive IOL (FineVision)

Outcomes

Primary Outcome Measures

Visual Acuity
Current study used Sloan chart (Good - Lite Co, USA) for intermediate, Snellen chart for far and Landolt ring chart for near vision
Defocus curve
examined monocular and binocular after correcting distant VA refractive error then inserting defocus lenses 0.50-D focus steps from (+1.50 to -3.50 D) in the trial frame

Secondary Outcome Measures

Contrast sensitivity
using the CSV-1000 contrast test.
Visual Satisfaction Questionnaire
Questionnaire patient satisfaction protocol mediated by (PhysIOL Lige, Belgium).

Full Information

First Posted
June 28, 2020
Last Updated
July 6, 2020
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT04465279
Brief Title
Trifocal Diffractive Intraocular Lens After Cataract Extraction With Phacoemulsification
Official Title
Evaluation of Trifocal Diffractive Intraocular Lens After Cataract Extraction With Phacoemulsification
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
October 15, 2018 (Actual)
Primary Completion Date
May 15, 2020 (Actual)
Study Completion Date
June 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Multifocal IOLs that maintain distance focus and improve near vision have been developed to reduce spectacle dependence.Multifocal IOLs improve patient performance of near-vision tasks, such as reading crafts, hobbies, and social activities to a greater extent than do monofocal IOLs. However, halos and reduced contrast sensitivity have been associated with multifocal IOLs and are common reasons for patient's dissatisfaction.Trifocal technology has been developed to create intermediate focus to overcome these difficulties. Continuous reports of the visual outcomes of the FineVision trifocal IOLs are encouraging.
Detailed Description
Monofocal IOLs, which provide effective distance vision, currently account for the majority of IOLs implantations. Patients who have undergone cataract surgery with implantation of monofocal IOL may require spectacles to perform near-distance (e.g., reading) or intermediate-distance (e.g., using a computer) tasks depending on their visual demandsMultifocal IOLs that maintain distance focus and improve near vision have been developed to reduce spectacle dependence.Multifocal IOLs improve patient performance of near-vision tasks, such as reading crafts, hobbies, and social activities to a greater extent than do monofocal IOLs. However, halos and reduced contrast sensitivity have been associated with multifocal IOLs and are common reasons for patient's dissatisfaction.Trifocal technology has been developed to create intermediate focus to overcome these difficulties. Continuous reports of the visual outcomes of the FineVision trifocal IOLs are encouraging.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Errors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Model Description
This is a prospective, non-comparative, non-randomized study including 36 eyes had implantation of trifocal diffractive IOL
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trifocal Diffractive Intraocular Lens (FineVision)
Arm Type
Experimental
Arm Description
36 eyes having implantation of trifocal diffractive IOL (FineVision)
Intervention Type
Device
Intervention Name(s)
Trifocal diffractive intraocular lens
Other Intervention Name(s)
(FineVision IOL)
Intervention Description
Trifocal IOL having foldable single-piece fully diffractive pupil dependent aspheric IOL. Which have been made of hydrophilic acrylic with an ultraviolet (UV) and blue light inhibitor. It has an optic diameter of 6.15 mm and an overall diameter of 10.75 mm; it has +3.5D additional power for near vision and +1.75 D additional power for intermediate vision, consisting of 26 diffractive steps.
Primary Outcome Measure Information:
Title
Visual Acuity
Description
Current study used Sloan chart (Good - Lite Co, USA) for intermediate, Snellen chart for far and Landolt ring chart for near vision
Time Frame
3 months
Title
Defocus curve
Description
examined monocular and binocular after correcting distant VA refractive error then inserting defocus lenses 0.50-D focus steps from (+1.50 to -3.50 D) in the trial frame
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Contrast sensitivity
Description
using the CSV-1000 contrast test.
Time Frame
3 months
Title
Visual Satisfaction Questionnaire
Description
Questionnaire patient satisfaction protocol mediated by (PhysIOL Lige, Belgium).
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patient eyes had cataract with no other pathology, patients desire for spectacle independence after surgery and with realistic expectation. Exclusion Criteria: Any ocular comorbidity that affect the end results of the surgery, history of ocular trauma, irregular corneal astigmatism, pupil abnormalities and capsular or zonular abnormalities that may affect postoperative centration as tilt of the lens (e.g. pseudo exfoliation syndrome and Marfan's syndrome).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ehab Mossallam, PhD
Organizational Affiliation
Alexandria Faculty of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alexandria Faculty of Medicine
City
Alexandria
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33849466
Citation
Zein El-Dein AA, Elmassry A, El-Hennawi HM, Mossallam EF. Objective and subjective evaluation of trifocal diffractive intraocular Lens after cataract extraction with phacoemulsification: a prospective clinical study. BMC Ophthalmol. 2021 Apr 14;21(1):179. doi: 10.1186/s12886-021-01937-z.
Results Reference
derived

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Trifocal Diffractive Intraocular Lens After Cataract Extraction With Phacoemulsification

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