Comparison of Clinical Outcomes POD L GF vs POD F GF in Asian Eyes

Launched by BEAVER-VISITEC INTERNATIONAL, INC. · Sep 26, 2018

Keywords

ClinConnect Summary

This is a prospective, randomised, controlled, single-surgeon, single-center clinical study whereby patients undergoing routine cataract surgery will have bilateral implantation of trifocal intraocular lenses. The patients will either be implanted with the hydrophobic IOL FineVision POD L GF or the hydrophobic IOL FineVision POD F GF (both lenses: (PhysIOL, Liège, Belgium).

The devices under investigation (FineVision POD L GF and POD F GF) are trifocal glistening-free acrylic intraocular lenses (IOLs) manufactured by the sponsor of this study PhysIOL sa/nv. Both consist of the same hydroph...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Cataractous eyes with no comorbidity
• • Availability, willingness and sufficient cognitive awareness to comply with examination procedures
• • Signed informed consent
• Exclusion Criteria:
• • Age of patient \<40 years
• • Irregular astigmatism
• • Regular corneal astigmatism \>0.75 dioptres by an automatic keratometer or biometer or \>1.0 dioptres if the steep axis of cylinder is between 90° and 120°
• • Difficulty for cooperation (distance from their home, general health condition)
• • Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc...)
• • Any ocular comorbidity
• • History of ocular trauma or prior ocular surgery including refractive procedures
• • Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic Uveitis, Marfan's syndrome)
• • Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions)
• • AMD suspicious eyes (determined by OCT)