Presbyopic Phakic Intraocular Lens for Myopia Correction
1 other identifier
interventional
10
1 country
1
Brief Summary
This is a prospective single-center study of implantations of the presbyopic version of phakic intraocular lens IPCL (EyeolUK, United Kingdom).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedFirst Submitted
Initial submission to the registry
February 6, 2019
CompletedFirst Posted
Study publicly available on registry
February 11, 2019
CompletedMay 10, 2019
February 1, 2019
3 years
February 6, 2019
May 9, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Change in Uncorrected Distance Visual Acuity (UDVA)
Distance visual acuity tested without any correction
2 years
Change in Uncorrected Near Visual Acuity (UNVA)
Near visual acuity tested without any correction
2 years
Secondary Outcomes (4)
Change in Corrected Distance Visual Acuity (CDVA)
2 years
Change in Corrected Near Visual Acuity (CNVA)
2 years
Change in distance refraction
2 years
Change in near refraction
2 years
Study Arms (1)
Implantation phakic intraocular lens
EXPERIMENTALPresbyopic posterior chamber phakic intraocular lens IPCL implanted to the participants eye
Interventions
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.
Eligibility Criteria
You may qualify if:
- CDVA \< 0.3 LogMAR
- Presbyopia with moderate to high myopia
- Phakic
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gemini Eye Clinic
Zlín, 760 01, Czechia
Related Publications (1)
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.
PMID: 32050231DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2019
First Posted
February 11, 2019
Study Start
January 1, 2016
Primary Completion
December 31, 2018
Study Completion
December 31, 2018
Last Updated
May 10, 2019
Record last verified: 2019-02