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CompletedNCT03836898Updated May 10, 2019

Presbyopic Phakic Intraocular Lens for Myopia Correction

An interventional study of Presbyopic posterior chamber phakic intraocular lens IPCL in Presbyopia and Myopia, sponsored by Gemini Eye Clinic. Completed at 1 site in Czechia. Open to participants aged 38 Years to 50 Years. Per ClinicalTrials.gov, last updated 2019-05-10.

Sponsored by Gemini Eye Clinic · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 1 month after the study started (first participant enrolled Jan 2016, registered Feb 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
38 Years to 50 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Presbyopia
  • Myopia
03

In context

Presbyopia

330 studies on the registry are indexed under Presbyopia; 35 are open to participants now.

This study's enrollment of 10 is below the median of 60 across 271 interventional studies indexed under Presbyopia.

Browse Presbyopia studies →

Lead sponsor

Gemini Eye Clinic is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
38 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Implantation phakic intraocular lens

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

    Device: Presbyopic posterior chamber phakic intraocular lens IPCL

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.

06

What researchers measure

Primary outcomes

  1. Change in Uncorrected Distance Visual Acuity (UDVA)

    Distance visual acuity tested without any correction

    Time frame: 2 years

  2. Change in Uncorrected Near Visual Acuity (UNVA)

    Near visual acuity tested without any correction

    Time frame: 2 years

Secondary outcomes

  1. Change in Corrected Distance Visual Acuity (CDVA)

    Distance visual acuity tested with correction

    Time frame: 2 years

  2. Change in Corrected Near Visual Acuity (CNVA)

    Near visual acuity tested with correction

    Time frame: 2 years

  3. Change in distance refraction

    Expressed as spherical equivalent sp.Eq (D)

    Time frame: 2 years

  4. Change in near refraction

    Expressed as spherical equivalent sp.Eq (D)

    Time frame: 2 years

07

Study locations

1 site
  • Gemini Eye Clinic
    Zlín, 760 01, Czechia
08

References and documents

Publications

  • 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. PubMed 32050231 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 10, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03836898
Lead sponsor
Gemini Eye Clinic
Responsible party
Sponsor
First posted
Feb 11, 2019
Start date
Jan 1, 2016
Primary completion
Dec 31, 2018
Completion
Dec 31, 2018
Last update
May 10, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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