Myopia, myopie, bijziendheid, short-sightedness
Conditions
Interventions
Bilateral implantation of PIOL to correct myopia. (control PIOL vs study PIOL)
Sponsors
OPHTEC BV
Eligibility
Inclusion criteria
Inclusion criteria: Age >18 years; Axial myopia that can be fully corrected with a PIOL within the power range of -2.0 to -14.5 D (i.e.: myopia ranging from approximately -1.5 to -15.5 D, depending on keratometry values); Anticipated subjective astigmatism not exceeding 1.5 D in both eyes; Stable refraction (¡À0.5 D; ¡À1.0 D for refractive errors>10.0 D), as expressed by manifest refraction spherical equivalent (MRSE) for ¡Ý12 months prior to surgery, verified by consecutive refractions and/or medical records or prescription history; CDVA ¡Ý0.5 in each eye; UDVA ¡Ü 0.5 in each eye; Difference between cycloplegic and manifest refractions 45 years of age 2000 cells/mm2 Any subject who is expected to have residual postoperative cylindrical refractive error of up to 1.5 D has been given the opportunity to experience his/her best spectacle vision with anticipated spherical correction only, and is willing to proceed with the surgery; Availability, willingness and sufficient cognitive awareness and physical ability to comply with examination procedures throughout the entire duration of the study. No secondary surgical procedure planned during the course of the study (e.g. laser treatment to correct astigmatism).
Exclusion criteria
Exclusion criteria: Ocular condition that can predispose for future complications or interfere with the ability to evaluate the safety or effectiveness of the lens; Acute or chronic disease or illness that would increase the operative risk or confound the outcome(s) of the study; Use of systemic or ocular medications that can confound the outcome of the study or increase the risk to the subject; Concurrent participation or participation during the last 30 days in any other clinical trial; Prior intraocular or corneal surgery; Patient, when examined preoperatively, not expected to achieve a postoperative CDVA of 0.5 or better; Insufficient space for the intended implant (ACD measured from epithelium 2 mm displacement from geometric center of cornea); Pupil >7 mm under scotopic conditions; Ocular hypertension (>21 mm Hg) Less than the minimal endothelial cell density as listed under inclusion criteria; Coefficient of variation of endothelial cell area ¡Ý0.45 (in both eyes); Endothelial disease that may potentially affect the visual outcome; History of retinal detachment; Evidence of retinal vascular disease or history of hypercoagulability; Glaucomatous changes in the retina or visual field; Glaucoma or glaucoma suspect; Any form of cataract; Corticosteroid responder; Active intraocular inflammation or recurrent ocular inflammatory condition; Monocular vision; Amblyopia;Microphthalmos or macrophthalmos; Immuno-compromised by steroids and/or antimetabolites; Pregnant, lactating, or plans to become pregnant during the course of the study Condition associated with fluctuation of hormones that could lead to refractive changes; Diabetes mellitus; Mentally retarded; Aged under 18; Surgical difficulty at the time of surgery which might increase the potential for complications; Not able to meet the extensive postoperative evaluation requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the adverse event rates, uncorrected and best-corrected visual acuity, 1 day to 6 months post-operative, not exceeding the reference safety and performance endpoint (SPE) rates as defined the ISO grid (ISO 11979-7 Annex B), and cataract not exceeding 2%. | — |
Secondary
| Measure | Time frame |
|---|---|
| CDVA, UDVA, MSRE, SIA, ECC, QOV, PIOL - endothelium clearance. | — |
Contacts
Public ContactE. Bouwman
Schweitzerlaan 15
Outcome results
None listed