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

Not Applicable

Completed

• Conditions: Patient Satisfaction; Patient Related Outcome Measures; Intraocular Lens Implant; Light Scatter; Phacoemulsification; Cataract Surgery; Cataract Extraction; Glistenings; Hydrophobic Acrylic
• Interventions: Device: Cataract surgery

• Registration Number: NCT03364972
• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-21
• Study First Submitted QC: 2017-12-06
• Study First Posted: 2017-12-07
• Study Start: 2018-02-06
• Status Verified: 2019-08
• Primary Completion: 2019-08-01
• Study Completion: 2019-08-01
• Last Update Submitted: 2019-08-05
• Last Update Posted: 2019-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 145

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard intraocular lens implant	Cataract surgery	Abbott Tecnis PCB00- Standard monofocal,hydrophobic acrylic intraocular lens implant
Experimental intraocular lens implant	Cataract surgery	'Alcon Clareon' : New monofocal, hydrophobic acrylic intraocular lens implant

Primary Outcome Measures

Name	Time	Method
Visual acuity	13 months	As measured by conventional LogMAR visual acuity charts

Secondary Outcome Measures

Name	Time	Method
Incidence of intraocular lens glistenings	13 months	Incidence of presence of intraocular lens glistenings in each study arm
Refraction (i.e. glasses prescription)	13 months	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
Severity of intraocular lens glistenings	13 months	Number of vacuoles per square millimetre

Trial Locations

Locations (1)

St Thomas' Hospital NHS Trust; 🇬🇧 London, United Kingdom