search
Back to results

Presbyopic Phakic Intraocular Lens for Myopia Correction

Primary Purpose

Presbyopia, Myopia

Status
Completed
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Presbyopic posterior chamber phakic intraocular lens IPCL
Sponsored by
Gemini Eye Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Presbyopia

Eligibility Criteria

38 Years - 50 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Gemini Eye Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Implantation phakic intraocular lens

Arm Description

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

Outcomes

Primary Outcome Measures

Change in Uncorrected Distance Visual Acuity (UDVA)
Distance visual acuity tested without any correction
Change in Uncorrected Near Visual Acuity (UNVA)
Near visual acuity tested without any correction

Secondary Outcome Measures

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

Full Information

First Posted
February 6, 2019
Last Updated
May 9, 2019
Sponsor
Gemini Eye Clinic
search

1. Study Identification

Unique Protocol Identification Number
NCT03836898
Brief Title
Presbyopic Phakic Intraocular Lens for Myopia Correction
Official Title
Presbyopic Phakic Intraocular Lens for Myopia Correction
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gemini Eye Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia, Myopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Implantation phakic intraocular lens
Arm Type
Experimental
Arm Description
Presbyopic posterior chamber phakic intraocular lens IPCL implanted to the participants eye
Intervention Type
Device
Intervention Name(s)
Presbyopic posterior chamber phakic intraocular lens IPCL
Intervention Description
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 Measure Information:
Title
Change in Uncorrected Distance Visual Acuity (UDVA)
Description
Distance visual acuity tested without any correction
Time Frame
2 years
Title
Change in Uncorrected Near Visual Acuity (UNVA)
Description
Near visual acuity tested without any correction
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Change in Corrected Distance Visual Acuity (CDVA)
Description
Distance visual acuity tested with correction
Time Frame
2 years
Title
Change in Corrected Near Visual Acuity (CNVA)
Description
Near visual acuity tested with correction
Time Frame
2 years
Title
Change in distance refraction
Description
Expressed as spherical equivalent sp.Eq (D)
Time Frame
2 years
Title
Change in near refraction
Description
Expressed as spherical equivalent sp.Eq (D)
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
38 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Gemini Eye Clinic
City
Zlín
ZIP/Postal Code
760 01
Country
Czechia

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32050231
Citation
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.
Results Reference
derived

Learn more about this trial

Presbyopic Phakic Intraocular Lens for Myopia Correction

We'll reach out to this number within 24 hrs