NCT06642779

Comparative Analysis of the Visual Performance and Patient Satisfaction After Cataract Surgery With Implantation of a Medicontur Monofocal (877PAY) or a Medicontur Extended Depth of Focus (877PEY) IOL

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 64 (actual)
• Sponsor: Medicontur Medical Engineering Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

The purpose of this multi-center, prospective, randomized, comparative clinical investigation was to evaluate and compare the visual performance at far, intermediate and near distances, the presence of photopic phenomena and patient satisfaction after cataract surgery in patients implanted binocularly with a Medicontur monofocal (877PAY) or a Medicontur extended depth of focus (877PEY) IOL models. The visit schedule included a total of 6 visits, in addition to the IOL implantation surgery, with the listed follow-up timeline: * screening and baseline assessments * day 0 (IOL implantation surgery) * day 1 * month 1 * month 3 * month 6 * month 12

Conditions

• Cataract
• Presbyopia
• Ametropia

Interventions

Type	Name	Description
BEHAVIORAL	VFQ- 25 (Visual Function Questionnaire)	VFQ-25 questionnaire was used to evaluate patient satisfaction at the M3 and M12 visits.
DIAGNOSTIC_TEST	Optical Biometry	Axial length, anterior chamber depth and corneal keratometric values K1-K2. All these parameters were measured at the screening visit and at the month 3 follow-up visit, using the ARGOS® Biometer or the ANTERION® Cataract App
DIAGNOSTIC_TEST	Slit lamps / Fundoscopy / Biomicroscopy	The fundus and other ocular structures, such as the cornea, anterior chamber, iris, pupil, crystalline lens / IOL alignment, corpus ciliare and choroid were examined at screening visit, on the day of the surgery, and at the follow up visits D1, M1, M3, M6, and M12, using the slit lamp binocular indirect ophthalmoscopy.
DIAGNOSTIC_TEST	UDVA	Monocular and binocular Uncorrected Distance Visual Acuity (UDVA) was evaluated at all visits (preoperative, D1, M1, M3, M6 and M12), using the ETDRS chart.
DIAGNOSTIC_TEST	CDVA	Monocular and binocular Corrected Distance Visual Acuity (UDVA) was evaluated at all visits (preoperative, D1, M1, M3, M6 and M12), using the ETDRS chart.
DIAGNOSTIC_TEST	UIVA / DCIVA	Uncorrected and Distance Corrected Intermediate Visual acuity (UIVA / DCIVA) was evaluated postoperatively at M1, M3, M6 and M12, using an intermediate chart from 67 cm.
DIAGNOSTIC_TEST	UNVA / DCNVA	Uncorrected and Distance Corrected Near Visual acuity (UNVA / DCNVA) was evaluated postoperatively at M1, M3, M6 and M12, using a near chart from 40 cm.
DIAGNOSTIC_TEST	Manifest Refraction	Manifest refraction was the monocular subjective refraction (Sph, Cyl, Axis) giving the best distance corrected visual acuity. It was measured at the screening visit and the follow-up visits Day 1, Month 1, Month 3, Month 6 and Month 12.
DIAGNOSTIC_TEST	IOP	Intraocular pressure (IOP) was measured at all visits (preoperative, D1, M1, M3, M6 and M12), using a non-contact tonometer.
DIAGNOSTIC_TEST	VADC	Visual Acuity Defocus Curve (VADC) was taken monocularly at M3, monocularly and binocularly at M6 and binocularly at M12, using the Multifocal Lens analyzer - MLA application.
DIAGNOSTIC_TEST	CSDC	Contrast Sinsitivity Defocus Curve (CSDC) was taken under photopic conditions at M6 and M12, using the Multifocal Lens Analyzer - MLA application
DIAGNOSTIC_TEST	CSV-1000	Contrast Sensitivity was measured using the CSV-1000 with distance correction in place at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd). Measurements were taken under four different light conditions: * Photopic (M3 monocular and binocular, M6 binocular and M12 monocular) * Mesopic (M6 binocular) * Photopic with backlight (M6 binocular) * Mesopic with backlight (M6 binocular)
DIAGNOSTIC_TEST	Tear film stability	Tear film stability was assessed at screening visit and at follow-up visits M1, M3, M6, and M12 using the non-invasive Tear break Up Time (TBUT) with fluorescein dye.
DEVICE	IOL implantation	The investigational device (877PEY) and the comparator (877PAY) intraocular lens models were implanted, using sutureless, small-incision phacoemulsification surgery.

Timeline

• Start date: 2020-12-02
• Primary completion: 2023-11-21
• Completion: 2024-01-24
• First posted: 2024-10-15
• Last updated: 2024-10-15

Locations

3 sites across 1 country: Hungary