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Completed

NCT Number: NCT03836898

Presbyopic Phakic Intraocular Lens for Myopia Correction

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

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Key information

Conditions

Presbyopia Eye Diseases Myopia Refractive Errors

Age range

38 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gemini Eye Clinic

Zlín, 760 01, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Presbyopic posterior chamber phakic intraocular lens IPCL

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.

Primary outcomes

  1. Change in Uncorrected Distance Visual Acuity (UDVA)

    Time frame: 2 years

    Distance visual acuity tested without any correction

  2. Change in Uncorrected Near Visual Acuity (UNVA)

    Time frame: 2 years

    Near visual acuity tested without any correction

Secondary outcomes

  1. Change in Corrected Distance Visual Acuity (CDVA)

    Time frame: 2 years

    Distance visual acuity tested with correction

  2. Change in Corrected Near Visual Acuity (CNVA)

    Time frame: 2 years

    Near visual acuity tested with correction

  3. Change in distance refraction

    Time frame: 2 years

    Expressed as spherical equivalent sp.Eq (D)

  4. Change in near refraction

    Time frame: 2 years

    Expressed as spherical equivalent sp.Eq (D)

Sponsors and collaborators

Lead sponsor

Gemini Eye Clinic

Industry

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 11, 2019
Registry last updated
May 10, 2019

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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