Trifocal Diffractive Intraocular Lens After Cataract Extraction With Phacoemulsification

Evaluation of Trifocal Diffractive Intraocular Lens After Cataract Extraction With Phacoemulsification

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.

Study Overview

• Status: Completed
• Conditions: Refractive Errors
• Intervention / Treatment: Device: Trifocal diffractive intraocular lens

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Alexandria Faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Trifocal Diffractive Intraocular Lens (FineVision); 36 eyes having implantation of trifocal diffractive IOL (FineVision)

Device: Trifocal diffractive intraocular lens; 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.; Other Names: (FineVision IOL)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Acuity	Current study used Sloan chart (Good - Lite Co, USA) for intermediate, Snellen chart for far and Landolt ring chart for near vision	3 months
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	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contrast sensitivity	using the CSV-1000 contrast test.	3 months
Visual Satisfaction Questionnaire	Questionnaire patient satisfaction protocol mediated by (PhysIOL Lige, Belgium).	3 months

Collaborators and Investigators

• Sponsor: Alexandria University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2018
• Primary Completion (Actual): May 15, 2020
• Study Completion (Actual): June 15, 2020

Study Registration Dates

• First Submitted: June 28, 2020
• First Submitted That Met QC Criteria: July 6, 2020
• First Posted (Actual): July 10, 2020

Study Record Updates

• Last Update Posted (Actual): July 10, 2020
• Last Update Submitted That Met QC Criteria: July 6, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Refractive Errors; Cataract; Capsule Opacification
• Other Study ID Numbers: 0000755

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No