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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02981186
• Other study ID #: PHY1603
• Status: Completed
• Phase: N/A
• Start date: November 2, 2016
• Est. completion date: September 25, 2017

Study information

• Verified date: May 2021
• Source: Beaver-Visitec International, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is a prospective randomised controlled study. The patients get monolateral IOL implantation of POD F GF and POD F in the contralateral eye. Both IOLs are trifocal IOLs consisting of the same optical design. The difference between the IOLs is the material (hydrophilic and hydrophobic).

To decide which eye receives POD F and which eye receives POD F GF, a randomization table will be provided to the principle investigator.

Description:

The examinations consist of visual acuity data, contrast sensitivity exams and slitlamp examinations.

Follow up will be up to 6 months postoperative.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 25, 2017
• Est. primary completion date: September 25, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cataract
• Lens Opacity

Intervention

Device:
• IOL implantation experimental
Implantation of trifocal IOL POD F GF consisting of hydrophobic material
• IOL implantation comparator
Implantation of trifocal IOL POD F consisting of hydrophilic material

Locations

Country	Name	City	State
Hungary	Semmelweis University - Department of Ophthalmology	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Beaver-Visitec International, Inc.

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Acuity at far, near and intermediate distance	ability to read letters at different distances	6 months postoperative