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Completed

NCT Number: NCT03027024

Clinical Study to Investigate Visual Performance of IOL: FineVision HP

This is a prospective, non-randomised, controlled, single-surgeon, single-center post-market clinical follow up study whereby patient undergoing routine cataract surgery will have bilateral implantation of a recently introduced TGA (Therapeutics Goods Authority, Australia) approved trifocal intraocular lens FineVision Evo (PhysIOL, Liège, Belgium). The primary and secondary effectiveness data for visual acuity, defocus curves, contrast sensitivity and any adverse events will be collected.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vision Eye Institute

Footscray, Victoria, 3011, Australia

About this study

Subjects participating in the trial will attend a total of 8 study visits (1 preoperative, 2 operative and 5 postoperative) over a period of 3 months, same as the surgeon's standard follow up protocol for bilateral cataract surgery with IOL implantation. Subjects would have the option for unscheduled visits if required medically.

Primary endpoint data will be collected at the final visit. Data analyses will be done in the end to support the study publication plan.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Cataracteous eyes with no comorbidity
  • 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
  • Regular corneal astigmatism >0.75 D on one or both eyes as measured by an automatic keratometer (regularity determined by the topography of the keratometry)
  • 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)
  • Complicated surgery

Treatment and study plan

Implantation of IOL: PhysIOL POD F GF

Device

Implantation of trifocal IOL POD F GF consisting of hydrophobic material

Other names: PhysIOL HP

Primary outcomes

  1. binocular Distance Corrected Near Visual Acuity (DCNVA)

    Time frame: 3 months postoperative

    measured in logMAR

Secondary outcomes

  1. monocular and binocular Uncorrected Distance Visual Acuity (UDVA)

    Time frame: 3 months postoperative

    measured in logMAR

  2. monocular and binocular Corrected Distance Visual Acuity (CDVA)

    Time frame: 3 months postoperative

    measured in logMAR

  3. monocular and binocular Uncorrected Intermediate Visual Acuity (UIVA)

    Time frame: 3 months postoperative

    measured in logMAR

  4. monocular and binocular Distance Corrected Intermediate Visual Acuity (DCIVA)

    Time frame: 3 months postoperative

    measured in logMAR

  5. monocular and binocular Uncorrected Near Visual Acuity (UNVA)

    Time frame: 3 months postoperative

    measured in logMAR

  6. monocular and binocular Distance Corrected Near Visual Acuity (DCNVA)

    Time frame: 3 months postoperative

    measured in logMAR

  7. Contrast Sensitivity (mesopic and photopic)

    Time frame: 3 months postoperative

    measured in logCS

Sponsors and collaborators

Lead sponsor

Beaver-Visitec International, Inc.

Industry

Registry information

Official study title

Clinical Study to Investigate Visual Performance of Hydrophobic Trifocal IOL: FineVision HP

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 20, 2017
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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