Binocular Vision in Monocular Pseudophakia

NCT01872000 | Terminated

• 1 other identifier: BVMP2013
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

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.

Conditions

Cataract

Keywords

Intraocular lens; Phacoemulsification

Outcome Measures

Primary Outcomes (1)

• Extent of binocular vision at near working distance following IOL implantation.

  3-6 months

Secondary Outcomes (1)

• Change in visual acuity and subjective visual comfort at distance, intermediate and near working distances following IOL implantation.

  3-6 months

Study Arms (2)

Multifocal IOL

EXPERIMENTAL

Phacoemulsification and IOL inserted following cataract surgery

Procedure: Cataract surgery

Standard IOL

ACTIVE COMPARATOR

Phacoemulsification and IOL inserted following cataract surgery

Procedure: Cataract surgery

Interventions

Cataract surgery PROCEDURE

Also known as: Phacoemulsification and IOL insertion

Multifocal IOL; Standard IOL

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oxford: lead
• Oxford University Hospitals NHS Trust: collaborator

Study Sites (2)

Oxford University Hospitals NHS Trust

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

Stoke Mandeville Hospital

Aylesbury, United Kingdom

Location

MeSH Terms

Conditions

Cataract

Interventions

Cataract Extraction; Phacoemulsification

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Ultrasonic Surgical Procedures

Study Officials

• Robert E MacLaren, DPhil

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2013
• First Posted: June 7, 2013
• Study Start: April 1, 2013
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: June 13, 2019

Record last verified: 2018-10

Locations

GB (2)