CataractBVMPNCT01872000
Binocular Vision in Monocular Pseudophakia
A study testing Cataract surgery in people with Cataract, run by University of Oxford at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Cataract
- What is being tested?
- Cataract surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Apr 2013to Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Show all 9Show fewer
- Target of emmetropia in the operated eye.
- Intact posterior capsule with planned implantation into the capsular bag.
- IOL power required 10 - 30D.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Stoke Mandeville Hospital
Aylesbury
Oxford University Hospitals NHS Trust
Oxford, Oxfordshire, OX3 9DU
About this study
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.
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.
- Conditions
- Cataract
- Being tested
- Cataract surgery
- Keywords
- Intraocular lens, Phacoemulsification
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cataract surgeryProcedure or surgery
Also called Phacoemulsification and IOL insertion
| Study group | Role | What they receive |
|---|---|---|
| Multifocal IOL | Experimental | Phacoemulsification and IOL inserted following cataract surgery Receives: Procedure: Cataract surgery |
| Standard IOL | Active comparator | Phacoemulsification and IOL inserted following cataract surgery Receives: Procedure: Cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extent of binocular vision at near working distance following IOL implantation.
Measured: 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.
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2013 (estimated)
- Study startApr 2013
- Primary completionOct 2018
- Study completionOct 2018
Why it stopped: Difficulties with recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Oxford University Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Robert E MacLaren, DPhil, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01872000
- Sponsor's protocol ID
- BVMP2013
- Acronym
- BVMP
- Status last verified
- Oct 2018
- First submitted
- 1 May 2013
- Last updated
- 13 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01872000
- Acronym / sponsor ID
- BVMP / BVMP2013
- Conditions
- Cataract
- Keywords
- Intraocular lens, Phacoemulsification
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties with recruitment.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Oxford University Hospitals NHS Trust
- Study start
- Apr 2013
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 7 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multifocal IOL | Experimental | Procedure: Cataract surgeryPhacoemulsification and IOL inserted following cataract surgery |
| Standard IOL | Active comparator | Procedure: Cataract surgeryPhacoemulsification and IOL inserted following cataract surgery |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cataract surgeryAlso: Phacoemulsification and IOL insertion | Procedure or surgery | Multifocal IOL, Standard IOL |
Primary outcome
Extent of binocular vision at near working distance following IOL implantation.
Time frame: 3-6 months
1 secondary outcome
Change in visual acuity and subjective visual comfort at distance, intermediate and near working distances following IOL implantation.
Time frame: 3-6 months
Results and safety
The study was stopped early (reason given: Difficulties with recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2019.
Related trials for Cataract
RecruitingPhase 4
Evaluating a Dropless Postoperative Regimen After Cataract Surgery in a Vulnerable, County-hospital Population
Cataract, Surgery
Recruiting
Trial Comparing miLOOP Device Assisted Phacoemulsification vs Standard Surgery for Dense Cataracts: Effects on Endothelial Cell Loss, Energy Use, and Vision Recovery
Cataract, Endothelial Cell Density
Not yet recruitingObservational study
PureSee/Odyssey Mix-and-Match IOL
Cataract
RecruitingPhase 3
Treatment of Retinal Detachment in People Who Have Not Had Cataract Surgery With Vitrectomy vs Vitrectomy and Cataract Removal
Rhegmatogenous Retinal Detachment
Not yet recruitingObservational study
A Case-Control Study Revealing Intraocular Microenvironment Characteristics in Patients With Ocular Diseases Based on Multi-Omics Analysis
Age- Related Macular Degeneration, Diabetic Retinopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert E MacLaren, DPhil principal investigator
University of Oxford
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cataract surgery in people with Cataract, run by University of Oxford at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficulties with recruitment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extent of binocular vision at near working distance following IOL implantation. (time frame: 3-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2019.