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Presbyopic Phakic Intraocular Lens for Myopia Correction

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ClinicalTrials.gov Identifier: NCT03836898
Recruitment Status : Completed
First Posted : February 11, 2019
Last Update Posted : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
Gemini Eye Clinic

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

Condition or disease Intervention/treatment Phase
Presbyopia Myopia Device: Presbyopic posterior chamber phakic intraocular lens IPCL Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Presbyopic Phakic Intraocular Lens for Myopia Correction
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   38 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03836898


Locations
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Czechia
Gemini Eye Clinic
Zlín, Czechia, 760 01
Sponsors and Collaborators
Gemini Eye Clinic

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Responsible Party: Gemini Eye Clinic
ClinicalTrials.gov Identifier: NCT03836898     History of Changes
Other Study ID Numbers: PhakicIOL Presbyopia
First Posted: February 11, 2019    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myopia
Presbyopia
Refractive Errors
Eye Diseases