Clinical Trial With Artiflex Presbyopic

Myopia Clinical Trial

Official title:

Prospective Multicentre Clinical Trial With the Artiflex Presbyopic, an Iris-fixated Multifocal Intraocular Lens for the Correction of Presbyopia in Phakic Eyes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04632784
• Other study ID #: AP01000816
• Status: Recruiting
• Phase: N/A
• Start date: November 12, 2021
• Est. completion date: July 2025

Study information

• Verified date: February 2022
• Source: Ophtec BV
• Contact: Erwin Bouwman, MSc
• Phone: +31 (0)6 83246222
• Email: study[@]ophtec.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this clinical trial is to evaluate the effectiveness and safety of the multifocal Artiflex Presbyopic intraocular lens.

Description:

The study is a prospective, open-label, single-arm, and multicentre clinical investigation with three years of follow-up. Artiflex Presbyopic is a phakic intraocular lens to be implanted in the anterior chamber, intended for adult subjects and indicated for the optical correction of presbyopia and spherical error requiring a correction. The results of this study will be used for CE-approval and registration as well as marketing purposes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: July 2025
• Est. primary completion date: July 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Presbyopic adult

• Potential for binocular vision

• Subject wishes to be spectacle independent for near and far vision

• Refractive error that can be corrected with correction at PIOL plane from +2.0 to -15.0 D

• Subject requiring a presbyopic correction

• Patients with reading glasses of minimum +1D

• Stable refraction (±0.75 D), as expressed by manifest refraction spherical equivalent (MRSE) for a minimum of 12 months prior to surgery, verified by consecutive refractions and/or medical records or prescription history

• Expected best-corrected visual acuity of 0.2 logMAR (0.63 Snellen decimal) or better after lens implantation

• Current contact lens wearer should demonstrate stable refraction (± 0.5 D), expressed as subjective refraction spherical equivalent, on two consecutive examination dates performed at least 7 days apart. Before the first refraction, the contact lens wearer should not have worn lenses for at least 2 weeks in case of rigid and toric contact lenses, or 3 days for spherical soft contact lenses.

• Any subject, who is expected to have a residual postoperative cylindrical refractive error of below 0.75 D

• Ability to give informed consent

• Availability, willingness and sufficient cognitive awareness and physical ability to comply with examination procedures throughout the entire duration of the study

Exclusion Criteria:

Pre-existing pathology or physiology which may be aggravated by the implant or where the implant may interfere with the possibility of examining or treating disease:

• Preoperative ocular or systemic condition or medication use that would be expected to present undue risk to the subject, that can predispose for future complications or confound the outcome(s) of the study.

E.g. the systemic use of alpha-1a adrenergic receptor antagonists was suggested to increase the occurrence of intraoperative floppy iris syndrome, alter iris morphology - or more specifically reduce iris thickness at the site of potential IOL enclavation - and increase postoperative endothelial cell loss.

• Previous ocular surgery which might affect the outcome of the study

• Concurrent participation or participation during the last 30 days in another drug or device investigation

• Secondary surgical procedure planned during the first 6 months of the study (e.g. laser treatment to correct astigmatism)

• Amblyopia

• Preoperative anterior chamber depth measurement of below 3.0 mm for subjects < 40 years old and 2.8 mm for subjects > 40 years old. Anterior chamber depth is being measured from corneal endothelium to the anterior pole of the crystalline lens. This will result in a critical distance between PIOL and endothelium of 1.5 mm or more as simulated with anterior segment imaging.

• White-to-white smaller than 10.5 mm

• Subjects not meeting the age specific minimum preoperative endothelial cell density as defined below:

31 to 35 years of age 2400 cells/mm2; 36 to 45 years of age 2200 cells/mm2; > 45 years of age 2000 cells/mm2

• Corneas with high rates of polymegethism (a coefficient of variation over 0.40) and pleomorphism (the presence of less than 50% hexagonal cells).

• Abnormal iris (e.g. convex, bulging or volcano shaped iris)

• Crystalline lens rise of 600 µm or more

• Abnormal cornea (keratoconus, opaque cornea, corneal scars, post corneal transplant, corneal dystrophy, or other)

• Ocular surface conditions which might influence the quality of vision and affect the outcome of the study

• Abnormal pupil (e.g. nonreactive, fixed)

• Ectopic pupil

• Pupil in photopic light conditions smaller than 2.6 mm

• Pupil in scotopic light conditions greater than 7.0 mm

• High preoperative intraocular pressure (>21 mm Hg)

• Cataract of any grade

• Glaucoma or family history of glaucoma (dependent on the evaluation of physician)

• Diabetes or diabetic retinopathy

• Acute or chronic inflammation

• Chronic or recurrent uveitis or family history of the same condition

• Retinal detachments or family history of retinal detachments

• Corticosteroid responder

• Pregnant or nursing

• Aged under 18

Related Conditions & MeSH terms

• Ametropia
• Hyperopia
• Myopia
• Presbyopia
• Refractive Errors

Intervention

Device:
• Artiflex Presbyopic implantation
Implantation of iris-fixated multifocal Artiflex Presbyopic IOL

Locations

Country	Name	City	State
Korea, Republic of	GM st. Mary's Eye clinic	Busan
Korea, Republic of	Seoul ST. Mary's Hospital	Seoul
Korea, Republic of	SU Yonsei Eye Clinic	Seoul
Korea, Republic of	Nune Eye Hospital Daegu	Seul
Korea, Republic of	Nune Eye Hospital Seoul	Seul	Seoul
Netherlands	Maastricht UMC+	Maastricht	Limburg
Spain	IMO	Barcelona	Catalonia
Spain	ICQO	Bilbao	Biscay
Spain	Instituto oftalmologico de madrid	Madrid
Spain	Vision Diez	Madrid
Spain	CIMO	Seville

Sponsors (1)

Lead Sponsor	Collaborator
Ophtec BV

Countries where clinical trial is conducted

Korea, Republic of,  Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in monocular and binocular uncorrected near visual acuity (UNVA)	Percentage of eyes that achieve UNVA of 0.3 logMAR or better; Percentage of eyes that achieve UNVA of 0.0 logMAR or better	3 years
Primary	Improvement in monocular and binocular corrected near visual acuity (CNVA)	Percentage of eyes that achieve CNVA of 0.3 logMAR or better; Percentage of eyes that achieve CNVA of 0.0 logMAR or better	3 years
Primary	Improvement in monocular and binocular distance corrected near visual acuity (DCNVA)	Percentage of eyes that achieve DCNVA of 0.3 logMAR or better; Percentage of eyes that achieve DCNVA of 0.0 logMAR or better	3 years
Primary	Improvement in monocular and binocular uncorrected intermediate visual acuity (UIVA)	Percentage of eyes that achieve UIVA of 0.3 logMAR or better; Percentage of eyes that achieve UIVA of 0.0 logMAR or better	3 years
Primary	Improvement in monocular and binocular distance corrected intermediate visual acuity (DCIVA)	Percentage of eyes that achieve DCIVA of 0.3 logMAR or better; Percentage of eyes that achieve DCIVA of 0.0 logMAR or better	3 years
Primary	Improvement in monocular and binocular uncorrected distance visual acuity (UDVA)	Percentage of eyes that achieve UDVA of 0.3 logMAR or better Percentage of eyes that achieve UDVA of 0.0 logMAR or better	3 years
Primary	Improvement in monocular and binocular corrected distance visual acuity (CDVA)	Percentage of eyes that achieve CDVA of 0.3 logMAR or better; Percentage of eyes that achieve CDVA of 0.0 logMAR or better	3 years
Primary	Defocus evaluation	Binocular defocus evaluation will be obtained by using the best-corrected distance refraction and then defocusing the image in 0.5 D increments from +1.5 to -5.0 D	3 years
Primary	Predictability of the manifest refraction spherical equivalent (MRSE)	The absolute difference between the actually obtained MRSE and the target MRSE	3 years
Primary	Predictability of the manifest refraction spherical equivalent (MRSE)	The percentage of eyes that achieves a MRSE of less than or equal to 0.5 D difference between the actual and target MRSE	3 years
Primary	Predictability of the manifest refraction spherical equivalent (MRSE)	The percentage of eyes that achieves a MRSE of less than or equal to 1.0 D difference between the actual and target MRSE	3 years
Primary	Stability of manifest refraction spherical equivalent (MRSE)	Mean change in MRSE between visits as determined by a paired analysis	3 years
Primary	Stability of manifest refraction spherical equivalent (MRSE)	The percentage of eyes that achieves a change in MRSE of less than or equal to 0.5 D between two consecutive refraction measurements	3 years
Primary	Stability of manifest refraction spherical equivalent (MRSE)	The percentage of eyes that achieves a change in MRSE of less than or equal to 1.0 D between two consecutive refraction measurements	3 years
Primary	Evaluation of visual disturbances using a validated questionnaire	Assessing the percentage of subjects who experience different visual disturbances, by means of questionnaire	3 years
Primary	Evaluation of visual disturbances using a validated questionnaire	Assessing the occurrence of the different visual disturbances by means of questionnaire	3 years
Primary	Evaluation of visual disturbances using a validated questionnaire	Assessing the severity of the different visual disturbances by means of questionnaire	3 years
Primary	Evaluation of visual disturbances using a validated questionnaire	Assessing the bothersomeness of the different visual disturbances by means of questionnaire	3 years
Primary	Evaluation of visual disturbances using a validated questionnaire	Assessing the time of onset of visual disturbances by means of questionnaire	3 years
Primary	Satisfaction questionnaire	Percentage of subjects that is satisfied with the overall procedure; Percentage of subjects that is satisfied with uncorrected near vision; Percentage of subjects that is satisfied with uncorrected intermediate vision; Percentage of subjects that is satisfied with uncorrected distance vision	3 years
Primary	Endothelial cell density	Comparison of the preoperative and postoperative endothelial cell density	3 years
Primary	Endothelial cell density	Endothelial cell loss over time	3 years
Primary	Endothelial cell density	Additionally, a comparison between the scientific literature reported naturally occurring endothelial cell loss over time (approx. 0.6% per year; Bourne et al., 1997) and the study observed cell loss will be performed	3 years
Primary	Adverse event (AEs) / complication rates	Cumulative numbers of adverse events, e.g. cystoid macular edema (CME), hypopyon, endophthalmitis, lens dislocation, pupillary block, retinal detachment, necessary secondary surgical interventions; Cumulative numbers of adverse events persistently present, e.g. corneal stroma edema, cystoid macular edema, iritis, raised intraocular pressure (IOP) requiring treatment, lens deposits; The occurrence of adverse events will be compared to and should not exceed the reference safety and performance endpoint (SPE) rates as defined by ISO 11979-7:2018, Annex E, table E.1	3 years