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This study will evaluate the clinical performance of a phakic intraocular lens (IOL) for the improvement of Uncorrected Near Visual Acuity (UCNVA) in subjects who require between +1.00 and +2.50 Reading Add.
Full description
This is a prospective, open-labeled, multi-site evaluation of clinical performance of the STAAR EVO+ Visian™ Implantable Collamer® Lens (VICL) with Aspheric (EDOF) Optic [EDOF ICL] for the improvement of UCNVA in subjects who require between +1.00 and +2.50 Reading Add.
Approximately 48 subjects who meet all eligibility criteria will undergo EDOF ICL implantation in both eyes. All eyes will be followed for 6 months after surgery.
The first eye implanted with the study lens and the appropriate time for fellow eye implantation will be determined by the medical judgement of the Investigator. All eyes will be analyzed for safety and performance.
The primary performance endpoint is defined as achievement of monocular UCNVA of Snellen equivalent 20/40 or better at 40 cm at 6 months after implantation in equal to or greater than 75% of implanted eyes.
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Inclusion criteria
Must be able to read, understand and provide written informed consent,
Willing and able to comply with all treatment and follow-up study related procedures,
40 - 60 years of age at time of surgery if require spherical lens powers from -0.50 D to -18.00 D,
35 - 45 years of age at time of surgery if require a spherical lens power from 0.0 D to +3.00 D,
Preoperative refraction fully correctable with available lens powers, with ≤ 0.75 D preoperative refractive and residual cylinder,
< 0.75 D spherical equivalent difference between cycloplegic and manifest refractions,
Stable correction (± 0.50 D) as determined by manifest refraction spherical equivalent (MRSE),
Best Corrected Distance Visual Acuity 20/20 or better in both eyes,
Requires +1.00 D to +2.50 D reading add,
Anterior chamber depth (ACD) ≥ 2.8 mm if require spherical lens powers from -0.50 D to -18.00 D,
ACD ≥ 3.0 mm if require spherical lens powers from 0.00 D to +3.00 D,
Anterior chamber angle ≥ Grade III,
Phakic in both eyes,
Current contact lens wearers need to demonstrate a stable refraction, (± 0.5 D), expressed as MRSE, on two consecutive examination dates with refractive stability determined by the following criteria:
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41 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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