Clinical Evaluation of the Lenstec Softec HP1 Intraocular Lens (NCT03900260) | Clinical Trial Compass
CompletedNot Applicable
Clinical Evaluation of the Lenstec Softec HP1 Intraocular Lens
United Kingdom87 participantsStarted 2019-04-25
Plain-language summary
The study is designed as a post market evaluation of the Softec HP1 IOL for continuance of the CE certificate. The primary effectiveness endpoint is to evaluate the safety and performance levels produced by this IOL in patients requiring standard cataract surgery. There will be no change from standard procedure, other than 1 extra post op evaluation.
Who can participate
Age range21 Years
SexALL
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Inclusion criteria
✓. ≥ 21 years of age, of any race and either gender
✓. Operable, age related cataract grade in one or both eyes
✓. Patients who require an IOL power in the range of 10.0 - 30.0 D only
✓. Able to comprehend and sign a statement of informed consent
✓. Planned cataract removal by phacoemulsification
✓. Potential postoperative visual acuity of 0.2 logMAR or better
✓. No other ocular or systemic pathology that may affect visual outcome following cataract surgery
✓. Clear intraocular media other than cataract in study eyes
Exclusion criteria
✕. Previous intraocular surgery
✕. Previous corneal refractive surgery
✕. Any inflammation or oedema (swelling) of the cornea
✕. Pterygium with corneal involvement or has the potential of corneal involvement (in the opinion of the Investigator)