Comparison of Visual Outcomes After Implantation of the POD AY GF F (PhysIOL) and the POD AY 26P F (PhysIOL)

• Register: ClinicalTrials.gov
• Last refreshed on: 17 May 2021
• Main ID: NCT02981186
• Date of registration: 29/11/2016
• Prospective Registration: No
• Primary sponsor: Beaver-Visitec International, Inc.
• Public title: Comparison of Visual Outcomes After Implantation of the POD AY GF F (PhysIOL) and the POD AY 26P F (PhysIOL)
• Scientific title: Comparison of Visual Outcomes After Implantation of the POD AY GF F (PhysIOL) and the POD AY 26P F (PhysIOL)
• Date of first enrolment: November 2, 2016
• Target sample size: 25
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02981186
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Hungary

Contacts

• Name: Zoltan Nagy, MD
• Affiliation: Semmelweis University - Department of Ophthalmology

Key inclusion & exclusion criteria

Inclusion Criteria:

- Cataractous Eyes with no comorbidity

- Patient older than 50 years old

- Regular corneal astigmatism <0.75 dioptres by an automatic keratometer (regularity
determined by the topography of the keratometry) or <1.0 dioptres if the steep axis of
cylinder is between 90° and 120°

- Spontaneously emitting the desire for spectacle independence after surgery and with
realistic expectation.

- Availability, willingness and sufficient cognitive awareness to comply with
examination procedures

- Signed informed consent

Exclusion Criteria:

- Unrealistic expectation

- Irregular astigmatism

- 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)



Age minimum: 50 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Lens Opacity

Cataract

Intervention(s)

Device: IOL implantation experimental

Device: IOL implantation comparator

Primary Outcome(s)

Visual Acuity at far, near and intermediate distance [Time Frame: 6 months postoperative]

Secondary ID(s)

PHY1603

Source(s) of Monetary Support

Please refer to primary and secondary sponsors