A Study Comparing Two Monofocal, Aspheric, Hydrophobic Acrylic Intraocular Lenses: the Alcon CLAREON® and the Abbott Medical Optics PCB00

Guy's and St Thomas' NHS Foundation Trust145 enrolled

Overview

This is a bilateral randomised controlled study to compare visual performance, refractive outcome, forward light scatter, patient satisfaction and objective measurement of glistenings following insertion of two monofocal, aspheric, hydrophobic acrylic intraocular lenses (IOLs). A new product is compared with an established one.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

145

Conditions

Cataract Extraction Phacoemulsification Glistenings Intraocular Lens Implant Hydrophobic Acrylic Cataract Surgery

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * bilateral cataracts * good visual potential * ability to understand informed consent and objectives of the trial * not-pregnant * not breast feeding * no previous eye surgery * corneal astigmatism less than 1 diopter in both eyes Exclusion Criteria: * age-related macula degeneration * glaucoma * previous retinal vascular disorders * previous retinal detachment or tear * any neuro-ophthalmological condition * any inherited retinal disorder or pathology * previous strabismus surgery or record of amblyopia * previous transient ischaemic attacks, cerebrovascular events or other vaso-occlusive disease * already enrolled in another study * Exclusion criteria relate to clinical contraindications for Femtosecond Laser Assisted Cataract Surgery, such as: * Significant corneal opacities * Small pupils following pharmacological dilatation * Patients unable to lie sufficiently flat so as to be positioned underneath the laser machine

Outcomes

Primary Outcomes

Visual acuity

As measured by conventional LogMAR visual acuity charts

Time frame: 13 months

Secondary Outcomes

Incidence of intraocular lens glistenings

Incidence of presence of intraocular lens glistenings in each study arm

Time frame: 13 months

Severity of intraocular lens glistenings

Number of vacuoles per square millimetre

Time frame: 13 months

Refraction (i.e. glasses prescription)

In conventional sphere/cylinder dioptre scales: total range -40 to +40, in 0.25 steps. Higher values represent worse outcome. Values closer to 0 (zero) represent better outcome

Time frame: 13 months

A Study Comparing Two Monofocal, Aspheric, Hydrophobic Acrylic Intraocular Lenses: the Alcon CLAREON® and the Abbott Medical Optics PCB00

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes