Implantation of a Trifocal Hydrophobic IOL in Patients That Underwent Refractive Surgery

NCT04054427 | Withdrawn

• 1 other identifier: PHY1902
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Controlled, open label, prospective Post Market Clinical Follow-Up, single-center clinical study to investigate visual performance after implantation of a trifocal IOL (PhysIOL Pod L GF) in patients that underwent refractive surgery.

Conditions

Cataract; Lens Opacities; Presbyopia

Keywords

Intraocular Lens; Trifocal; hydrophobic; Post refractive surgery

Outcome Measures

Primary Outcomes (1)

• Monocular Best Corrected Distance Visual Acuity (CDVA)

  Statistically significant non-inferiority with POD L GF on monocular CDVA in comparison to literature data. A significance level of 0.05 will be considered statistically significant.

  6 months (120-180 days) postoperative

Secondary Outcomes (38)

• Manifest refraction (sphere and cylinder)

  Pre-OP, 1-2 days post operative, 30-60 days postoperative, 120-180 days postoperative

• Pupil Size Photopic

  120-180 days postoperative

• Pupil Size Mesopic

  120-180 days postoperative

• Uncorrected Distance Visual Acuity (UDVA) - monocular

  Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative

• Uncorrected Distance Visual Acuity (UDVA) - binocular

  120-180 days postoperative

Other Outcomes (5)

• Intraocular pressure (IOP) measurement

  Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative

• Keratometry

  Pre-OP

• Biometry

  Pre-OP

Study Arms (1)

IOL implantation experimental

EXPERIMENTAL

hydrophobic, trifocal intraocular lens POD L GF

Device: IOL implantation experimental

Interventions

IOL implantation experimental DEVICE

Implantation of trifocal IOL POD L GF consisting of hydrophobic material

IOL implantation experimental

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cataracteous eyes with no comorbidity;
• Post LASIK, post PRK/surface ablation or post RK (radial keratotomy) patients with day of refractive surgery minimum 24 months before IOL implantation;
• Calculated IOL power is within the range of the study IOLs;
• Fulfill CHRU (Centre Hospitalier Regional Universitaire) internal criteria for multifocal lenses implantation on post-refractive surgery patients.
• Male or female adults ages 45 years or older on the day of screening who have cataract(s) in one or both eyes or suffer from presbyopia;
• Clear intraocular media other than cataract;
• Availability, willingness and sufficient cognitive awareness to comply with examination procedures;
• Signed informed consent

You may not qualify if:

• Age of patient \< 45 years;
• Irregular topographic examination where limitation in clinical outcomes are expected.
• Patients that underwent presbyopia correcting refractive surgery (e.g. PresbyLASIK, SUPRACOR, INTRACOR)
• Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal or optic disorders) that are predicted to cause future acuity losses to a level of 20/30 or worse;
• Subjects with AMD suspicious eyes as determined by OCT examination;
• Subjects who may be expected to require retinal laser treatment during the course of the study or at a greater risk of developing cystoid macular edema;
• Traumatic cataract;
• History or presence of macular edema;
• Concurrent or previous (within 30 days) participation in another drug or device investigation;
• Instability of keratometry or biometry measurements;
• Ocular hypertension or glaucoma;
• Significant dry eye;
• Unsuitable for study participation for any other reason, as determined by Investigator's clinical judgement (reason to be documented on the CRF).

Sponsors & Collaborators

• Beaver-Visitec International, Inc.: lead

MeSH Terms

Conditions

Cataract; Presbyopia

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors

Study Officials

• Béatrice Cochener, Prof

  Département d'ophtalmologie - CHU Morvan Bâtiment 4 bis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2019
• First Posted: August 13, 2019
• Study Start: November 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: October 7, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share