MedPath

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

Completed
Conditions
Presbyopia and astigmatism
Eye Diseases
Registration Number
ISRCTN10869381
Lead Sponsor
Viewpoint Vision Services Ltd
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
20
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) 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

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

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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