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TerminatedNCT01872000BVMPUpdated Jun 13, 2019

Binocular Vision in Monocular Pseudophakia

An interventional study of Cataract surgery in Cataract, sponsored by University of Oxford. Terminated at 2 sites in United Kingdom. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2019-06-13.

Sponsored by University of Oxford · Not applicable, Interventional, and Treatment

Why this study was terminated
Difficulties with recruitment.
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

Following cataract surgery, an intraocular lens (IOL) is implanted in the eye. The majority of people develop an operable cataract when they are over the age of 50. Occasionally people under 50 years develop a cataract requiring an operation. The visual demands in this age group are very different due to both physiological and lifestyle factors. Traditionally IOLs are focussed for distance vision and additional spectacles are worn for near vision. Under the age of 45 years we have the ability to naturally change the focus of our eyes and do not require additional reading glasses. This is known as accommodation. By removing the cataractous lens and replacing it with an IOL with a fixed single focus, both eyes work together for distance vision but only the unoperated eye is able to change focus for different working distances. This study aims to establish whether a multifocal IOL implanted in one eye is able to complement the accommodation in the other eye so the 2 eyes work more effectively together. This may enhance depth perception and improve the quality of vision. Depth perception is important for more comfortable vision on the computer screen, when reading and for jobs that require good depth perception.

02

Conditions studied

  • Cataract

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Keywords

  • Intraocular lens
  • Phacoemulsification
03

In context

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's enrollment of 12 is below the median of 80 across 1,155 interventional studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

University of Oxford is the lead sponsor of 794 studies on the registry; 117 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Participant is willing and able to give informed consent for participation in the study.
  • Male or female, aged 18 - 45.
  • Cataract operation required in one eye only, either due to the presence of cataract affecting visual function, or in combination with surgery which is likely to cause visually significant cataract.
  • Expected visual improvement in operable eye of at least 6/12.
  • Fellow eye with a VA of at least 6/9.
  • Astigmatism of 1.0D or less.
  • Target of emmetropia in the operated eye.
  • Intact posterior capsule with planned implantation into the capsular bag.
  • IOL power required 10 - 30D.

Exclusion criteria

Exclusion Criteria:

  • Pre-existing amblyopia or squint.
  • Significant diabetic retinopathy.
  • Macular off retinal detachment with metamorphopsia or poor visual prognosis.
  • Other macula or ophthalmic pathology affecting macula function resulting in poor visual prognosis.
  • Pregnancy, lactating or planned pregnancy during the study period.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    Multifocal IOL

    Phacoemulsification and IOL inserted following cataract surgery

    Procedure: Cataract surgery

  • Active comparator
    Standard IOL

    Phacoemulsification and IOL inserted following cataract surgery

    Procedure: Cataract surgery

Interventions

  • ProcedureCataract surgery

    Also known as: Phacoemulsification and IOL insertion

06

What researchers measure

Primary outcomes

  1. Extent of binocular vision at near working distance following IOL implantation.

    Time frame: 3-6 months

Secondary outcomes

  1. Change in visual acuity and subjective visual comfort at distance, intermediate and near working distances following IOL implantation.

    Visual acuity at different distances will be presented in combination as they are linked.

    Time frame: 3-6 months

07

Study locations

2 sites
  • Oxford University Hospitals NHS Trust
    Oxford, Oxfordshire OX3 9DU, United Kingdom
  • Stoke Mandeville Hospital
    Aylesbury, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 13, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01872000
Lead sponsor
University of Oxford
Collaborators
Oxford University Hospitals NHS Trust
Responsible party
Sponsor
First posted
Jun 7, 2013
Start date
Apr 2013
Primary completion
Oct 2018
Completion
Oct 2018
Last update
Jun 13, 2019

Study contacts

Robert E MacLaren, DPhil
principal investigator · University of Oxford

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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