Global Multicenter Study with the Hydrophobic Acrylic (HF) Iris-Fixated PIOL for the Correction of Myopia in Phakic Eyes
- Conditions
- myopianearsightedness10047518
- Registration Number
- NL-OMON40527
- Lead Sponsor
- OPHTEC BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 100
• 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 <= 0.5 in each eye;
• Difference between cycloplegic and manifest refractions < 0.75 D;
• Current contact lens wearer has a stable refraction (± 0.5 D) on 2 consecutive examination dates at least 7 days apart, and the lenses were not worn for at least 2 weeks for rigid and toric contact lenses, or 3 days for spherical soft contact lenses prior to the first refraction;
• Minimum ACD of 3.2 mm (from epithelium to anterior lens capsule) by biometry, resulting in a critical distance between PIOL and endothelium of 1.5 mm or more as simulated with anterior segment imaging;
• Age specific, minimum endothelial cell density as follows (According to ISO11979-10):;18 to 25 years of age 2800 cells/mm2;
26 to 30 years of age 2650 cells/mm2;
31 to 35 years of age 2400 cells/mm2;
36 to 45 years of age 2200 cells/mm2;
> 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).
• 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 <3.2mm);
• Abnormal iris (e.g. bulging or volcano shaped iris, aniridia);
• Abnormal cornea (e.g., keratoconus, opaque cornea, recurrent erosion syndrome, scars, or other cornea pathologies);
• Abnormal pupil (e.g. nonreactive, fixed, photopic diameter <2.0 mm);
• Ectopic pupil (>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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To evaluate the safety and effectiveness of the HF IF PIOL, by documenting:<br /><br><br /><br>• adverse event rates and best-corrected visual acuity (BCVA), 6 months<br /><br>post-operative (safety);<br /><br>• the improvement in uncorrected distance visual acuity (UDVA) at 6 months post<br /><br>operative (efficacy);<br /><br>• the predictability (attempted versus achieved) of the MSRE;<br /><br>• the stability of spherical equivalent;<br /><br>• the endothelial cell density decrease after stabilization of the surgically<br /><br>induced cell loss (1to 6 months post-operative);<br /><br>• subject satisfaction on resulting visual outcome.<br /><br><br /><br>In these, establishing the safety profile using adverse event rates and visual<br /><br>acuity is considered the primary objective of the study. Additional objectives<br /><br>are considered secondary.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary objective is to compare the safety and effectiveness of the study<br /><br>lens with the Artiflex Myopia PIOL. The outcome of the comparison will be used<br /><br>to determine how the study lens performs compared to the Artiflex Myopia PIOL,<br /><br>especially regarding occurrence of deposits and endothelial clearance, with a<br /><br>comparable safety profile.</p><br>