myopia nearsightedness
Conditions
Interventions
Subjects will receive the HF IF PIOL in one randomly assigned eye and the CE
certified Artiflex Myopia PIOL in the other eye. Surgical procedure and
medication regime are standard for phakic iris-fi
Sponsors
OPHTEC BV
Eligibility
Age
18 Years to 99 Years
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 (±0.5 D; ±1.0 D for refractive errors>10.0 D), as expressed by manifest refraction spherical equivalent (MRSE) for >=12 months prior to surgery, verified by consecutive refractions and/or medical records or prescription history; • CDVA >=0.5 in each eye; • UDVA 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 >=0.45 (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 |
|---|---|
| To evaluate the safety and effectiveness of the HF IF PIOL, by documenting: • adverse event rates and best-corrected visual acuity (BCVA), 6 months post-operative (safety); • the improvement in uncorrected distance visual acuity (UDVA) at 6 months post operative (efficacy); • the predictability (attempted versus achieved) of the MSRE; • the stability of spherical equivalent; • the endothelial cell density decrease after stabilization of the surgically induced cell loss (1to 6 months post-operative); • subject satisfaction on resulting visual outcome. In these, establishing the safety profile using adverse event rates and visual acuity is considered the primary objective of the study. Additional objectives are considered secondary. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective is to compare the safety and effectiveness of the study lens with the Artiflex Myopia PIOL. The outcome of the comparison will be used to determine how the study lens performs compared to the Artiflex Myopia PIOL, especially regarding occurrence of deposits and endothelial clearance, with a comparable safety profile. | — |
Countries
Netherlands
Outcome results
None listed