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 Trust

Status: Completed

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

Treatments: Device: Cataract surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT03364972

232017

Details and patient eligibility

About

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.

Enrollment: 145 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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145 participants in 2 patient groups

Experimental intraocular lens implant

Experimental group

Description:

'Alcon Clareon' : New monofocal, hydrophobic acrylic intraocular lens implant

Treatment:

Device: Cataract surgery

Standard intraocular lens implant

Active Comparator group

Description:

Abbott Tecnis PCB00- Standard monofocal,hydrophobic acrylic intraocular lens implant

Treatment:

Device: Cataract surgery