Presbyopic Phakic Intraocular Lens for Myopia Correction

NCT ID: NCT03836898

Last Updated: 2019-05-10

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

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-01

Study Completion Date

2018-12-31

Brief Summary

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This is a prospective single-center study of implantations of the presbyopic version of phakic intraocular lens IPCL (EyeolUK, United Kingdom).

Detailed Description

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Participants are impanted with the phakic intraocular lens IPCL (EyeolUK, United Kingdom) and monitored during 2 years period. Visual acuity for near and distance is evaluated, along with refraction and endothelium cell density.

Conditions

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Presbyopia Myopia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Implantation phakic intraocular lens

Presbyopic posterior chamber phakic intraocular lens IPCL implanted to the participants eye

Group Type EXPERIMENTAL

Presbyopic posterior chamber phakic intraocular lens IPCL

Intervention Type DEVICE

Presbyopic posterior chamber phakic intraocular lens IPCL (EyeolUK, United Kingdom) has a refractive optic and diffractive trifocal pattern on its anterior optical surface to correct both distance and near refractive errors. Presbyopic addition is manufactured in a range of +1.0 to + 4.0 diopters (D) in 0.5 D steps.

Interventions

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Presbyopic posterior chamber phakic intraocular lens IPCL

Presbyopic posterior chamber phakic intraocular lens IPCL (EyeolUK, United Kingdom) has a refractive optic and diffractive trifocal pattern on its anterior optical surface to correct both distance and near refractive errors. Presbyopic addition is manufactured in a range of +1.0 to + 4.0 diopters (D) in 0.5 D steps.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* CDVA \< 0.3 LogMAR
* Presbyopia with moderate to high myopia
* Phakic

Exclusion Criteria

* Corneal endotehleial cell density below 2000 cells/mm2
* Corneal dystrophies
* ACD less than 2.8 mm
* history or current uveitis
* acute ocular inflammation
* glaucoma
* chronic uveitis
* previous intraocular or refractive surgery
* preexisting ocular pathologic which may affect postoperative results
Minimum Eligible Age

38 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gemini Eye Clinic

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Gemini Eye Clinic

Zlín, , Czechia

Site Status

Countries

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Czechia

References

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Stodulka P, Slovak M, Sramka M, Polisensky J, Liska K. Posterior chamber phakic intraocular lens for the correction of presbyopia in highly myopic patients. J Cataract Refract Surg. 2020 Jan;46(1):40-44. doi: 10.1097/j.jcrs.0000000000000033.

Reference Type DERIVED
PMID: 32050231 (View on PubMed)

Other Identifiers

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PhakicIOL Presbyopia

Identifier Type: -

Identifier Source: org_study_id

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