Clinical Study to Investigate Outcomes of Trifocal Toric IOL POD FT in Asian Eyes

NCT03844828 | Active Not Recruiting

• 1 other identifier: PHY1901
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective, controlled, single-surgeon, single-center clinical study to compare visual acuity outcomes to data obtained in a similar study by the same principal investigator on the trifocal IOL POD F (study no. PHY1802, ClinicalTrials.gov ID: NCT03688425)

Conditions

Cataract; Lens Opacities; Presbyopia

Keywords

Intraocular Lens; Trifocal; Toric Lens

Outcome Measures

Primary Outcomes (1)

• Monocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions.

  Monocular visual acuity outcomes on CDVA under photopic light conditions are statistically non-inferior to data obtained in a similar study by the same principal investigator on the trifocal IOL POD F (study no. PHY1802, ClinicalTrials.gov ID: NCT03688425).

  6 months (120-180 days) postoperative

Secondary Outcomes (32)

• Manifested refraction

  Pre-OP, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative

• Pupil Size

  6 months postoperative

• Uncorrected Distance Visual Acuity (UDVA) - monocular

  Pre-OP, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative

• Uncorrected Distance Visual Acuity (UDVA) - binocular

  6 months postoperative, 12 months postoperative, 24 months postoperative

• Corrected Distance Visual Acuity (CDVA) - monocular

  Pre-OP, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative

Other Outcomes (5)

• Intraocular pressure (IOP) measurement

  Pre-OP, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative

• Keratometry

  Pre-OP

• Biometry

  Pre-OP

Study Arms (1)

POD FT IOL Implantation experimental

EXPERIMENTAL

Mono- or bilateral implantation of trifocal toric intraocular lenses POD FT and POD F.

Device: IOL implantation experimental

Interventions

IOL implantation experimental DEVICE

Mono- or bilateral implantation of trifocal toric intraocular lenses POD FT. If both eyes of the same patient qualify for the implantation of a trifocal toric lens, a bilateral implantation will be performed. If only one eye qualifies for a trifocal toric lens, the contralateral eye will be implanted with the spherical trifocal IOL POD F (both lenses: (PhysIOL, Liège, Belgium).

Also known as: POD FT IOL implantation

POD FT IOL Implantation experimental

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Regular corneal astigmatism ≥0.75 dioptres (measured by an automatic keratometer or biometer) in one or both eyes;
• Capability to understand and sign an IRB approved informed consent form and privacy authorization;
• Clear intraocular media other than cataract;
• Calculated IOL power is within the range of the study IOLs;
• Dilated pupil size large enough to visualize IOL axis markings postoperatively;
• Willing and able to conform to the study requirements.

You may not qualify if:

• Regular corneal astigmatism \<0.75 dioptres (measured by an automatic keratometer or biometer) in both eyes
• Irregular astigmatism;
• 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;
• Previous intraocular or corneal surgery;
• Traumatic cataract;
• History or presence of macular edema;
• Pregnant, lactating or, if able to bear children, unwilling to use medically acceptable birth control over the course of the study;
• 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 judgment (reason to be documented on eCRF).

Sponsors & Collaborators

• Beaver-Visitec International, Inc.: lead

Study Sites (1)

Asian Eye Institute

Makati City, 1200, Philippines

Location

MeSH Terms

Conditions

Cataract; Presbyopia

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors

Study Officials

• Robert Edward Ang, MD

  Asian Eye Institute

  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: February 13, 2019
• First Posted: February 19, 2019
• Study Start: March 25, 2019
• Primary Completion: November 22, 2025
• Study Completion: December 1, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

PH (1)