Binocular Vision in Monocular Pseudophakia (BVMP)
Primary Purpose
Cataract
Status
Terminated
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Cataract surgery
Sponsored by
About this trial
This is an interventional treatment trial for Cataract focused on measuring Intraocular lens, Phacoemulsification
Eligibility Criteria
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.
Sites / Locations
- Oxford University Hospitals NHS Trust
- Stoke Mandeville Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Multifocal IOL
Standard IOL
Arm Description
Phacoemulsification and IOL inserted following cataract surgery
Phacoemulsification and IOL inserted following cataract surgery
Outcomes
Primary Outcome Measures
Extent of binocular vision at near working distance following IOL implantation.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01872000
First Posted
May 1, 2013
Last Updated
June 12, 2019
Sponsor
University of Oxford
Collaborators
Oxford University Hospitals NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT01872000
Brief Title
Binocular Vision in Monocular Pseudophakia
Acronym
BVMP
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 Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Terminated
Why Stopped
Difficulties with recruitment.
Study Start Date
April 2013 (undefined)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
October 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oxford
Collaborators
Oxford University Hospitals NHS Trust
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Intraocular lens, Phacoemulsification
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Multifocal IOL
Arm Type
Experimental
Arm Description
Phacoemulsification and IOL inserted following cataract surgery
Arm Title
Standard IOL
Arm Type
Active Comparator
Arm Description
Phacoemulsification and IOL inserted following cataract surgery
Intervention Type
Procedure
Intervention Name(s)
Cataract surgery
Other Intervention Name(s)
Phacoemulsification and IOL insertion
Primary Outcome Measure Information:
Title
Extent of binocular vision at near working distance following IOL implantation.
Time Frame
3-6 months
Secondary Outcome Measure Information:
Title
Change in visual acuity and subjective visual comfort at distance, intermediate and near working distances following IOL implantation.
Description
Visual acuity at different distances will be presented in combination as they are linked.
Time Frame
3-6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert E MacLaren, DPhil
Organizational Affiliation
University of Oxford
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oxford University Hospitals NHS Trust
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Facility Name
Stoke Mandeville Hospital
City
Aylesbury
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Binocular Vision in Monocular Pseudophakia
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