Presbyopic Phakic Intraocular Lens for Myopia Correction

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03836898

Enrollment

Registered

2019-02-11

Start date

2016-01-01

Completion date

2018-12-31

Last updated

2019-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia, Presbyopia

Brief summary

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

Detailed description

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.

Interventions

DEVICEPresbyopic 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

38 Years to 50 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change in Uncorrected Distance Visual Acuity (UDVA)	2 years	Distance visual acuity tested without any correction
Change in Uncorrected Near Visual Acuity (UNVA)	2 years	Near visual acuity tested without any correction

Secondary

Measure	Time frame	Description
Change in Corrected Distance Visual Acuity (CDVA)	2 years	Distance visual acuity tested with correction
Change in Corrected Near Visual Acuity (CNVA)	2 years	Near visual acuity tested with correction
Change in distance refraction	2 years	Expressed as spherical equivalent sp.Eq (D)
Change in near refraction	2 years	Expressed as spherical equivalent sp.Eq (D)

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026