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BVMP: Binocular Vision in Monocular Pseudophakia

Sponsor
University of Oxford (Other)
Overall Status
Terminated
CT.gov ID
NCT01872000
Collaborator
Oxford University Hospitals NHS Trust (Other)
12
Enrollment
2
Locations
2
Arms
66
Duration (Months)
6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
  • Procedure: Cataract surgery
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
12 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 :
Apr 1, 2013
Actual Primary Completion Date :
Oct 1, 2018
Actual Study Completion Date :
Oct 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Multifocal IOL

Phacoemulsification and IOL inserted following cataract surgery

Procedure: Cataract surgery
Other Names:
  • Phacoemulsification and IOL insertion

    		•
    Active Comparator: Standard IOL

    Phacoemulsification and IOL inserted following cataract surgery

    Procedure: Cataract surgery
    Other Names:
  • Phacoemulsification and IOL insertion

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Extent of binocular vision at near working distance following IOL implantation. [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. [3-6 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Oxford University Hospitals NHS Trust Oxford Oxfordshire United Kingdom OX3 9DU
    2 Stoke Mandeville Hospital Aylesbury United Kingdom

    Sponsors and Collaborators

    • University of Oxford
    • Oxford University Hospitals NHS Trust

    Investigators

    • Principal Investigator: Robert E MacLaren, DPhil, University of Oxford

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Oxford
    ClinicalTrials.gov Identifier:
    NCT01872000
    Other Study ID Numbers:
    • BVMP2013
    First Posted:
    Jun 7, 2013
    Last Update Posted:
    Jun 13, 2019
    Last Verified:
    Oct 1, 2018
    Keywords provided by University of Oxford
    Intraocular lens
    Phacoemulsification
    Additional relevant MeSH terms:
    Cataract

    Study Results

    No Results Posted as of Jun 13, 2019