NCT01654159

Brief Summary

The main objective of this research is to assess visual function and optical performance of CE marked, implanted intraocular lenses to understand the individual factors that affect their performance and how these may be improved in future designs and to evaluate measurement techniques. All outcome measures will be captured 3-6 months after surgery

Trial Health

75
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
56mo left

Started Sep 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress74%
Sep 2013Nov 2030

First Submitted

Initial submission to the registry

July 17, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 31, 2012

Completed
1.1 years until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
17.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2030

Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

17.3 years

First QC Date

July 17, 2012

Last Update Submit

January 19, 2026

Conditions

Cataract

Keywords

intraocular lensesevaluationcataract

Outcome Measures

Primary Outcomes (1)

  • Unaided distance and near vision

    Visual Acuity (logMAR)

    Measured at 3-6 months after surgery

Secondary Outcomes (4)

  • Patient Satisfaction

    Measured at 3-6 months after surgery

  • Residual refraction

    Measured at 3-6 months after surgery

  • Aberrations

    Measured at 3-6 months after surgery

  • Corrected distance and near acuity

    Measured at 3-6 months after surgery

Study Arms (3)

Monofocal

PLACEBO COMPARATOR

Monofocal IOL Implant Manufacturers of IOLs used as monofocal comparator are Alcon, AMO, Bausch and Lomb, Lenstec, Oculentis, Ophthec, Physiol and Zeiss

Procedure: Monofocal IOL

Multifocal

EXPERIMENTAL

Multifocal IOL Manufacturers of multifocal IOLs under investigation are Alcon, AMO, Bausch and Lomb, Lenstec, Oculentis, Ophthec, Physiol and Zeiss

Procedure: Multifocal IOL

Toric

EXPERIMENTAL

Toric IOL Manufacturers of toric IOLs under investigation are Alcon, AMO, Bausch and Lomb, Lenstec, Oculentis, Ophthec, Physiol and Zeiss

Procedure: Toric IOL

Interventions

Multifocal IOLPROCEDURE

Multifocal IOL will be implanted

Multifocal
Toric IOLPROCEDURE

Toric IOLS will be implanted

Toric
Monofocal IOLPROCEDURE

Monofocal Intraocular lens will be implanted

Also known as: Alcon AMO B&L Lenstec Oculentis Ophthec Physiol & Zeiss
Monofocal

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects age between 40-85 years, may be either male or female, and may be of any race (as cataracts rarely occur before the age of 40 and above 85 other ocular pathology is common).
  • Subjects requiring cataract surgery.
  • Potential for best corrected visual acuity of 6/12 or better (as visual function in these patients will be affected by ocular pathology).
  • Subjects with clear intraocular media other than cataract (as assessing cataract).
  • General physical and mental condition allowing participation in current study.
  • Subjects willing to participate as evidenced by signing the written informed

You may not qualify if:

  • Prior surgery on the selected eye
  • Previous uveitis or trauma to the selected eye, anterior or posterior synechiae
  • Potential for best corrected visual acuity worse than 6/12 (since this may indicate other causes of ocular pathology)
  • Partial or total paralysis, Parkinsons syndrome, cerebrovascular accident or other condition that could impact on the results of the study
  • Subject over 85 years of age (ocular pathology more common in this age group)
  • Subjects without adequate physical and mental capacity to enable participation in the study
  • Subject unwilling to participate
  • Systemic or topical medication known to influence visual function measures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Birmingham Midland Eye Centre

Birmingham, West Midlands, B18 7QH, United Kingdom

Location

MeSH Terms

Conditions

Cataract

Interventions

Multifocal Intraocular Lenses

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Lenses, IntraocularLensesOptical DevicesEquipment and SuppliesProstheses and Implants

Study Officials

  • Sunil Shah, FRCS

    Birmingham Midland Eye Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2012

First Posted

July 31, 2012

Study Start

September 1, 2013

Primary Completion (Estimated)

November 30, 2030

Study Completion (Estimated)

November 30, 2030

Last Updated

January 21, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

Data collaboration will be considered on request

Locations

GB(1)