NCT03364972

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
145

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 7, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

February 6, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

August 6, 2019

Status Verified

August 1, 2019

Enrollment Period

1.5 years

First QC Date

November 21, 2017

Last Update Submit

August 5, 2019

Conditions

Cataract ExtractionPhacoemulsificationGlisteningsIntraocular Lens ImplantHydrophobic AcrylicCataract SurgeryLight ScatterPatient SatisfactionPatient Related Outcome Measures

Keywords

cataractcataract extractioninterocular lens implantglisteningsphacoemulsificationhydrophobic acryliclight scatterpatient related outcome measures

Outcome Measures

Primary Outcomes (1)

  • Visual acuity

    As measured by conventional LogMAR visual acuity charts

    13 months

Secondary Outcomes (3)

  • Incidence of intraocular lens glistenings

    13 months

  • Severity of intraocular lens glistenings

    13 months

  • Refraction (i.e. glasses prescription)

    13 months

Other Outcomes (4)

  • Forward light scatter

    13 months

  • Contrast sensitivity

    13 months

  • Patient satisfaction

    13 months

  • +1 more other outcomes

Study Arms (2)

Experimental intraocular lens implant

EXPERIMENTAL

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

Device: Cataract surgery

Standard intraocular lens implant

ACTIVE COMPARATOR

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

Device: Cataract surgery

Interventions

Cataract surgeryDEVICE

Conventional small-incision phacoemulsification cataract surgery with insertion of intraocular lens implant

Experimental intraocular lens implantStandard intraocular lens implant

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Significant corneal opacities
  • Small pupils following pharmacological dilatation
  • Patients unable to lie sufficiently flat so as to be positioned underneath the laser machine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Thomas' Hospital NHS Trust

London, SE1 7EH, United Kingdom

Location

MeSH Terms

Conditions

Patient SatisfactionCataract

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehaviorLens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2017

First Posted

December 7, 2017

Study Start

February 6, 2018

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

August 6, 2019

Record last verified: 2019-08

Locations

GB(1)