Myopic astigmatism nearsightedness with a cylinder
Conditions
Interventions
All patients receive a phakic intraocular iris fixated anterior chamber lens
(ARTIFLEX Toric PIOL) in one or both eyes in a surgical procedure. After
surgery, the investigators ask the patients to c
Sponsors
OPHTEC BV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Stable refraction (±0.5 D; ±1.0 D for high refractive errors), as expressed by manifest refraction spherical equivalent (MRSE) for a minimum of 12 months prior to surgery, verified by consecutive refractions and/or medical records or prescription history; - Myopic astigmatism requiring correction within the range of the ARTIFLEX Toric PIOL. The investigators will receive an availability list when it becomes available. The calculated refraction can be 0.25 D lower or higher than the minimum or maximum available lens power for both the cylinder and the sphere (e.g. if the minimum cylinder will be 1.0 D, the minimum cylinder of the patient has to be 0.75 D after calculation); - A minimum BCVA of 0.5 in each eye; - UCVA of 0.5 or worse; - Less than 0.75 D difference between cycloplegic and manifest refractions; - Regular astigmatism.
Exclusion criteria
Exclusion criteria: Ocular conditions 1. Preoperative ocular condition that can predispose for future complications or interfere with the ability to evaluate the safety or effectiveness of the lens; 2. Abnormal iris (e.g. bulging or volcano shaped iris; abnormality which would preclude fixation such as aniridia); 3. Abnormal cornea (i.e., keratoconus, opaque cornea, scars, or other cornea pathologies resulting in irregular astigmatism); 4. Prior intraocular or corneal surgery; 5. Monocular vision; 6. Amblyopia; 7. Insufficient space for the intended implant (ACD 21 mmHg; 9. Abnormal pupil or pupil in low light > 7.0 mm (scotopic light: 45 years of age 2000 cells/mm2; 12. Surgical difficulty at the time of surgery which might increase the potential for complications;;Non-ocular conditions 13. Aged under 18 or above 60; 14. Acute or chronic illness that would increase the operative risk or confound the outcome(s) of the study; 15. Patients who are immuno-compromised by steroids and/or antimetabolites; 16. Subject is taking systemic medications that can confound the outcome of the study or increase the risk to the subject; 17. Subject is pregnant, plans to become pregnant, or is lactating during the course of the study, or has another condition associates with the fluctuation of hormones that could lead to refractive changes; 18. Diabetic mellitus; 19. Mentally retarded; 20. Patients that are not able to meet the extensive postoperative evaluation requirements;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Reduction of cylinder a. Magnitude of reduction (diopters); b. % of eyes within 0.5 and 1.0 from intended correction; 2. Lens axis misalignment (compared to intended position); 3. Mechanical stability (tilting, distortion, fixation of the lens). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Manifest Refraction Spherical Equivalent (MRSE); 2. Best spectacle corrected and uncorrected distant visual acuity; 3. Safety (adverse events, ECC, IOP) | — |
Countries
Netherlands
Outcome results
None listed