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OpenTrials
Completed

NCT Number: NCT04465279

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Alexandria Faculty of Medicine

Alexandria, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Trifocal diffractive intraocular lens

Device

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)

Primary outcomes

  1. Visual Acuity

    Time frame: 3 months

    Current study used Sloan chart (Good - Lite Co, USA) for intermediate, Snellen chart for far and Landolt ring chart for near vision

  2. Defocus curve

    Time frame: 3 months

    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 outcomes

  1. Contrast sensitivity

    Time frame: 3 months

    using the CSV-1000 contrast test.

  2. Visual Satisfaction Questionnaire

    Time frame: 3 months

    Questionnaire patient satisfaction protocol mediated by (PhysIOL Lige, Belgium).

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Evaluation of Trifocal Diffractive Intraocular Lens After Cataract Extraction With Phacoemulsification

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 10, 2020
Registry last updated
Jul 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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