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OpenTrials
Completed

NCT Number: NCT02981186

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

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases Lens Opacity

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Semmelweis University - Department of Ophthalmology

Budapest, 1085, Hungary

About this study

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

Follow up will be up to 6 months postoperative.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

IOL implantation experimental

Device

Implantation of trifocal IOL POD F GF consisting of hydrophobic material

IOL implantation comparator

Device

Implantation of trifocal IOL POD F consisting of hydrophilic material

Primary outcomes

  1. Visual Acuity at far, near and intermediate distance

    Time frame: 6 months postoperative

    ability to read letters at different distances

Sponsors and collaborators

Lead sponsor

Beaver-Visitec International, Inc.

Industry

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 5, 2016
Registry last updated
May 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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