Trifocal Diffractive Intraocular Lens After Cataract Extraction With Phacoemulsification

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-15

Study Completion Date

2020-06-15

Brief Summary

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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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Detailed Description

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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.

Conditions

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Refractive Errors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is a prospective, non-comparative, non-randomized study including 36 eyes had implantation of trifocal diffractive IOL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Trifocal Diffractive Intraocular Lens (FineVision)

36 eyes having implantation of trifocal diffractive IOL (FineVision)

Group Type EXPERIMENTAL

Trifocal diffractive intraocular lens

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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(FineVision IOL)

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No