Binocular Vision in Monocular Pseudophakia (BVMP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01872000
Recruitment Status : Unknown
Verified February 2016 by University of Oxford.
Recruitment status was:  Recruiting
First Posted : June 7, 2013
Last Update Posted : February 22, 2016
Oxford University Hospitals NHS Trust
Information provided by (Responsible Party):
University of Oxford

Brief 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.

Condition or disease Intervention/treatment Phase
Cataract Procedure: Cataract surgery Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Randomised Controlled Trial to Assess Improved Binocular Visual Function in Young Patients Undergoing Monocular Cataract Surgery With a Bifocal Intraocular Lens.
Study Start Date : April 2013
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Multifocal IOL
Phacoemulsification and IOL inserted following cataract surgery
Procedure: Cataract surgery
Other Name: Phacoemulsification and IOL insertion
Active Comparator: Standard IOL
Phacoemulsification and IOL inserted following cataract surgery
Procedure: Cataract surgery
Other Name: Phacoemulsification and IOL insertion

Primary Outcome Measures :
  1. Extent of binocular vision at near working distance following IOL implantation. [ Time Frame: 3-6 months ]

Secondary Outcome Measures :
  1. Change in visual acuity and subjective visual comfort at distance, intermediate and near working distances following IOL implantation. [ Time Frame: 3-6 months ]
    Visual acuity at different distances will be presented in combination as they are linked.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01872000

Contact: Jasleen K Jolly, MSc

United Kingdom
Oxford University Hospitals NHS Trust Recruiting
Oxford, Oxfordshire, United Kingdom, OX3 9DU
Contact: Jasleen K Jolly, MSc   
Principal Investigator: Robert E MacLaren, MB ChB DPhil         
Sub-Investigator: Jasleen K Jolly, MSc         
Sub-Investigator: C K Patel, MBBS         
Sub-Investigator: Paul Rosen, MB ChB         
Stoke Mandeville Hospital Recruiting
Aylesbury, United Kingdom
Contact: Judith Abrams         
Sponsors and Collaborators
University of Oxford
Oxford University Hospitals NHS Trust
Principal Investigator: Robert E MacLaren, DPhil University of Oxford

Responsible Party: University of Oxford Identifier: NCT01872000     History of Changes
Other Study ID Numbers: BVMP2013
First Posted: June 7, 2013    Key Record Dates
Last Update Posted: February 22, 2016
Last Verified: February 2016

Keywords provided by University of Oxford:
Intraocular lens

Additional relevant MeSH terms:
Lens Diseases
Eye Diseases