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

Patient Satisfaction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03364972
• Other study ID #: 232017
• Status: Completed
• Phase: N/A
• Start date: February 6, 2018
• Est. completion date: August 1, 2019

Study information

• Verified date: August 2019
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: August 1, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Cataract surgery
Conventional small-incision phacoemulsification cataract surgery with insertion of intraocular lens implant

Locations

Country	Name	City	State
United Kingdom	St Thomas' Hospital NHS Trust	London

Sponsors (3)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust	City, University of London, King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Forward light scatter	Intraocular (forward) light scatter is measured with a specifically devised computerised vision test. It is represented by straylight parameter, Log(s), on a logarithmic scale from 0 to 1.5. The lower the value (i.e. closer to 0), the better the outcome.	13 months
Other	Contrast sensitivity	Visual acuity (LogMAR scale: total range -0.2 to 1.0 in 0.02 steps) measured at different contrasts with a computerized contrast sensitivity chart. Negative values, or values closer to 0, represent better outcome.	13 months
Other	Patient satisfaction	Validated patient satisfaction questionnaire. We use specially designed and validated conversion tables to convert raw scores from questionnaires to Rasch calibrated measures.	13 months
Other	Self-reported health	Validated self-reported health questionnaire. We use a vertical Visual Analogue Scale (VAS) to record patients' self-reported health on a scale from 0-100 (values closer or equal to 100 represent better outcome).	13 months
Primary	Visual acuity	As measured by conventional LogMAR visual acuity charts	13 months
Secondary	Incidence of intraocular lens glistenings	Incidence of presence of intraocular lens glistenings in each study arm	13 months
Secondary	Severity of intraocular lens glistenings	Number of vacuoles per square millimetre	13 months
Secondary	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	13 months