Clinical Study to Compare Visual Performance of Two Trifocal IOLs

NCT ID: NCT03347981

Last Updated: 2021-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-02
• Study Completion Date: 2019-05-21

Brief Summary

Prospective, randomised, controlled, single-surgeon, single-center post-market clinical follow up study to compare the clinical outcomes of two trifocal IOLs with different material

Detailed Description

This is a prospective, randomised, controlled, single-surgeon, single-center post-market clinical follow up 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 F GF or the hydrophilic IOL FineVision Pod F.

The primary and secondary effectiveness data for visual acuity, contrast sensitivity, halometry, aberrometry, questionnaire outcomes and any adverse events will be collected.

Subjects participating in the trial will attend a total of 10 study visits (1 preoperative, 2 operative and 7 postoperative) over a period of 3 months. Subjects would have the option for unscheduled visits if required medically.

Primary endpoint data will be collected at the 3 months follow up visit. Data analyses will be done after the last patient finished the final examination to support the study publication plan.

Conditions

Cataract; Lens Opacities; Presbyopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IOL implantation experimental

hydrophobic, trifocal intraocular lens POD F GF

Group Type: EXPERIMENTAL

IOL implantation experimental

Intervention Type: DEVICE

Implantation of trifocal IOL POD F GF consisting of hydrophobic material

IOL implantation active comparator

hydrophilic, trifocal intraocular lens POD F

Group Type: ACTIVE_COMPARATOR

IOL implantation active comparator

Intervention Type: DEVICE

Implantation of trifocal IOL POD F consisting of hydrophilic material

Interventions

IOL implantation experimental

Implantation of trifocal IOL POD F GF consisting of hydrophobic material

Intervention Type: DEVICE

IOL implantation active comparator

Implantation of trifocal IOL POD F consisting of hydrophilic material

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Cataractous 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

• Irregular astigmatism
• Age of patient < 50 years
• Regular corneal astigmatism >1.00 dioptres by an automatic keratometer or biometer or >1.25 dioptres if the steep axis of cylinder is between 90° and 120° in one or both eyes
• 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)
• Complicated surgery

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beaver-Visitec International, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francisco Poyales Galan, MD

Role: PRINCIPAL_INVESTIGATOR

Innova Ocular IOA Madrid

Locations

Innova Ocular IOA Madrid

Madrid, , Spain

Countries

Spain

Other Identifiers

PHY1702

Identifier Type: -

Identifier Source: org_study_id