CompletedNot Applicable

Clinical Performance of a Phakic Intraocular Lens (IOL)

Belgium, Spain41 participantsStarted 2018-03-20

Plain-language summary

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.

Who can participate

Age range40 Years – 60 Years

SexALL

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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,

Exclusion criteria

✕. Participation in a clinical trial within 30 days prior to entry into this study and/or during the period of study participation,
✕. Previous intraocular or corneal surgery in either eye, including refractive surgery,
✕. Progressive sight threatening disease or other previous or current ocular conditions, other than myopia in either eye,
✕. Low/abnormal corneal endothelial cell density,
✕. Amblyopia,
✕. Presence of active or history of chronic inflammation in either eye,
✕. Clinically significant irregular astigmatism in either eye,
✕. Serious, acute, chronic or systemic, non-ophthalmic disease or illness that would increase the operative risk, confound the outcome(s) of the study or which may preclude study completion,

What they're measuring

Number of Eyes With Monocular Uncorrected Near Visual Acuity of 20/40 or Better at 40 cm 6 Months After Implantation

Timeframe: 6 months

Trial details

NCT IDNCT03499821

SponsorStaar Surgical Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-07-09

Results submitted2022-05-20

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