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A prospective randomised controlled trial comparing bilateral multifocal intraocular lens implantation with monovision following cataract surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN37400841
Enrollment
212
Registered
2007-01-29
Start date
2007-02-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract Eye Diseases Cataract

Interventions

Bilateral intraocular lens implant with either TECNIS ZM000 multifocal or Bausch and Lomb Akreos AO monofocal intraocular lenses.

Sponsors

Moorfields Eye Hospital NHS Foundation Trust (UK)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients requiring bilateral cataract surgery with good visual potential and a full visual field in each eye 2. Age range 30 to 90 years 3. Biometry indicating IOL power requirement within the range +10 to +30D for emmetropia (0.00 to -0.50D spherical equivalent) in both eyes

Exclusion criteria

Exclusion criteria: 1. Patients aiming for a refractive result other than bilateral emmetropia (0.00 to -0.50D spherical equivalant) or emmetropia in one eye and low myopia in the other, i.e., the intended monovision outcome 2. Significant co-pathology (including macular pathology, glaucoma, uveitis, corneal disease, diabetic retinopathy, previous retinal detachment surgery) 3. Keratometric astigmatism 1.5D in either eye 4. Amblyopia 5. Congenital or traumatic cataracts 6. Poor comprehension of written or spoken English 7. Inability to give informed consent 8. Mobility, tremor or postural problems causing discomfort during slit lamp examination

Design outcomes

Secondary

MeasureTime frame
1. Visual Function 14-question (VF14) questionnaire 2. Near visual acuity 3. Reading speed 4. Binolcular Logarithm of the Minimum Angle of Resolution (LogMAR) acuity 5. Binocular Pelli Robson contrast sensitivity - photopic and dark adapted 6. Procyon pupillometry 7. Forward light scatter - van den Berg forward light scatter test 8. Wavefront aberrations - Shack Hartmann aberrometry

Primary

MeasureTime frame
Percentage of patients with total spectacle independence

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026