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A six month clinical evaluation of the Toric Multifocal Intraocular Implant after cataract or lens replacement surgery

Safety and efficacy of a Toric Multifocal Intraocular Implant after routine Bilateral implantation following Cataract or Lens Refractive surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN10869381
Enrollment
20
Registered
2017-01-09
Start date
2017-03-01
Completion date
Unknown
Last updated
2017-02-06

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

Conditions

Presbyopia and astigmatism Eye Diseases Presbyopia and astigmatism

Interventions

Any patient presenting for Corrective eye surgery with Refractive lens exchange will undergo the standard pre operative assessment for suitability for this procedure. The pre operative assessment cons

Sponsors

Viewpoint Vision Services Ltd
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Male or female adults 2. Aged 21 to 80 years 3. Patient's who wish to be free of spectacles 4. Best distance corrected visual acuity projected to be better than 0.2 logMAR postoperatively (= 20/32 Snellen or 0.63 decimal) 5. Axial Length (AL) </= 25mm 6. Angle kappa<0.55mm (central optical zone of 1.11mm/2) measured with the wavefront iTrace aberrometer 7. Pupil size large enough to visualise the toric axis markings 8. Availability, willingness and sufficient cognitive awareness to comply with examination procedures 9. Signed informed consent 10. Patients suitable for Refractive lens exchange as a procedure to correct their refractive error

Exclusion criteria

Exclusion criteria: 1. Previous corneal or intraocular surgery 2. Corneal Pathology 3. uncontrolled glaucoma 4. Pseudoexfoliation syndrome 5. Retinal Detachment 6. Macular degeneration 7. Retinopathy 8. Evidence of previous uveitis 9. Amblyopia 10. Any pupil abnormalities 11. Previous ocular trauma 12. Patients with insufficient cognitive ability to undergo pre operative and post operative tests and assessments or unable to sign consent form themselves 13. Any per operative complications or deviation from the standard procedure

Design outcomes

Primary

MeasureTime frame
The rotational stability of the implant within the eye at 6 months compared with the axial position of the implant within 24 hours after surgery will be assessed by assessing the position of the implant on the slit lamp and by using digital retroillumination photographs at baseline (24 hours post-operatively), 1 week, 1 month, 3 month and 6 month post-operatively.

Secondary

MeasureTime frame
1. Subjective refraction is measured using subjective testing with lenses in a trial frame as at the opticians at baseline (pre-operatively), and 3 and 6 months post-operatively 2. Visual acuity at distance and for near at 40 cm both uncorrected and fully corrected and binocular acuity is measured using a Snellen chart in LogMAR units at basline, 1, 3 and 6 months post-operatively 3. Use of spectacles for distance or reading, presence of photic phenomenon and overall satisfaction with the procedure is measured using a questionnaire designed for the purpose of this study 3 and 6 months post-operatively

Countries

United Kingdom

Contacts

Public ContactDeepak Chitkara
deepak@viewpointvision.com+44 1744 646643

Outcome results

None listed

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