Presbyopic Phakic Intraocular Lens for Myopia Correction

May 9, 2019 updated by: Gemini Eye Clinic
This is a prospective single-center study of implantations of the presbyopic version of phakic intraocular lens IPCL (EyeolUK, United Kingdom).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Zlín, Czechia, 760 01
        • Gemini Eye Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gemini Eye Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

February 6, 2019

First Submitted That Met QC Criteria

February 8, 2019

First Posted (Actual)

February 11, 2019

Study Record Updates

Last Update Posted (Actual)

May 10, 2019

Last Update Submitted That Met QC Criteria

May 9, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PhakicIOL Presbyopia

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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