Presbyopic Phakic Intraocular Lens for Myopia Correction

Not Applicable

Completed

• Conditions: Myopia; Presbyopia
• Interventions: Device: Presbyopic posterior chamber phakic intraocular lens IPCL

• Registration Number: NCT03836898
• Lead Sponsor: 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).

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 Timeline

• Study Start: 2016-01-01
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2019-02
• Study First Submitted: 2019-02-06
• Study First Submitted QC: 2019-02-08
• Study First Posted: 2019-02-11
• Last Update Submitted: 2019-05-09
• Last Update Posted: 2019-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Implantation phakic intraocular lens	Presbyopic posterior chamber phakic intraocular lens IPCL	Presbyopic posterior chamber phakic intraocular lens IPCL implanted to the participants eye

Primary Outcome Measures

Name	Time	Method
Change in Uncorrected Distance Visual Acuity (UDVA)	2 years	Distance visual acuity tested without any correction
Change in Uncorrected Near Visual Acuity (UNVA)	2 years	Near visual acuity tested without any correction

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Gemini Eye Clinic; 🇨🇿 Zlín, Czechia