Clinical trial NCT03364972: A Study Comparing Two Monofocal, Aspheric, Hydrophobic Acrylic Intraocular Lenses: the Alcon CLAREON® and the Abbott Medical Optics PCB00
Official title: A 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: the Alcon CLAREON® and the Abbott Medical Optics PCB00 Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract Extraction
Phacoemulsification
Glistenings
Intraocular Lens Implant
Hydrophobic Acrylic
Cataract Surgery
Light Scatter
Patient Satisfaction
Patient Related Outcome Measures
Keywords: cataract
cataract extraction
interocular lens implant
glistenings
phacoemulsification
hydrophobic acrylic
light scatter
patient related outcome measures
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: City, University of London
name: King's College London
First posted: 2017-12-07
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Visual acuity
timeFrame: 13 months
Secondary outcomes:
measure: Incidence of intraocular lens glistenings
timeFrame: 13 months
measure: Severity of intraocular lens glistenings
timeFrame: 13 months
measure: Refraction (i.e. glasses prescription)
timeFrame: 13 months
Other outcomes:
measure: Forward light scatter
timeFrame: 13 months
measure: Contrast sensitivity
timeFrame: 13 months
measure: Patient satisfaction
timeFrame: 13 months
measure: Self-reported health
timeFrame: 13 months
Locations:
city: London
country: United Kingdom
facility: St Thomas' Hospital NHS Trust
Study officials:
References: