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Binocular Vision in Monocular Pseudophakia (BVMP)

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University of Oxford

Status

Terminated

Conditions

Cataract

Treatments

Procedure: Cataract surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT01872000
BVMP2013

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

12 participants in 2 patient groups

Multifocal IOL
Experimental group
Description:
Phacoemulsification and IOL inserted following cataract surgery
Treatment:
Procedure: Cataract surgery
Standard IOL
Active Comparator group
Description:
Phacoemulsification and IOL inserted following cataract surgery
Treatment:
Procedure: Cataract surgery

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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