Clinical trial NCT01872000: Binocular Vision in Monocular Pseudophakia
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
Overall status: TERMINATED
Phase: NA
Conditions: Cataract
Keywords: Intraocular lens
Phacoemulsification
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Oxford University Hospitals NHS Trust
First posted: 2013-06-07
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Extent of binocular vision at near working distance following IOL implantation.
timeFrame: 3-6 months
Secondary outcomes:
measure: Change in visual acuity and subjective visual comfort at distance, intermediate and near working distances following IOL implantation.
timeFrame: 3-6 months
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Trust
state: Oxfordshire
city: Aylesbury
country: United Kingdom
facility: Stoke Mandeville Hospital
Study officials:
affiliation: University of Oxford
name: Robert E MacLaren, DPhil
role: PRINCIPAL_INVESTIGATOR
References: