Presbyopic Phakic Intraocular Lens for Myopia Correction

Myopia Clinical Trial

Official title:

Presbyopic Phakic Intraocular Lens for Myopia Correction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03836898
• Other study ID #: PhakicIOL Presbyopia
• Status: Completed
• Phase: N/A
• Start date: January 1, 2016
• Est. completion date: December 31, 2018

Study information

• Verified date: February 2019
• Source: Gemini Eye Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 38 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Myopia
• Presbyopia

Intervention

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.

Locations

Country	Name	City	State
Czechia	Gemini Eye Clinic	Zlín

Sponsors (1)

Lead Sponsor	Collaborator
Gemini Eye Clinic

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Uncorrected Distance Visual Acuity (UDVA)	Distance visual acuity tested without any correction	2 years
Primary	Change in Uncorrected Near Visual Acuity (UNVA)	Near visual acuity tested without any correction	2 years
Secondary	Change in Corrected Distance Visual Acuity (CDVA)	Distance visual acuity tested with correction	2 years
Secondary	Change in Corrected Near Visual Acuity (CNVA)	Near visual acuity tested with correction	2 years
Secondary	Change in distance refraction	Expressed as spherical equivalent sp.Eq (D)	2 years
Secondary	Change in near refraction	Expressed as spherical equivalent sp.Eq (D)	2 years