Comparison of Clinical Outcomes on Trifocal IOLs FineVision POD F GF and FineVision POD F in Asian Eyes

NCT03306355 | Completed

• 1 other identifier: PHY 1706
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective, randomised, controlled, single-surgeon, single-center clinical study to compare the clinical outcomes of two trifocal IOLs with different material (hydrophobic and hydrophilic) from the same manufacturer. Implantation of the IOLs is bilaterally.

Conditions

Cataract; Lens Opacities; Presbyopia

Keywords

Intraocular Lens; trifocal; hydrophobic; hydrophilic

Outcome Measures

Primary Outcomes (1)

• Monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions.

  No statistically significant difference between the two study groups on monocular UDVA at 3 months follow up visit. A significance level of 0.05 or lower (p \< 0.05) will be considered statistically significant. UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014

  3 months postoperative

Secondary Outcomes (28)

• Manifested refraction

  Pre-OP, 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.

• Uncorrected Distance Visual Acuity (UDVA) - monocular

  1 day postoperative, 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.

• Uncorrected Distance Visual Acuity (UDVA) - binocular

  3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.

• Corrected Distance Visual Acuity (CDVA) - monocular

  Pre-OP, 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.

• Corrected Distance Visual Acuity (CDVA) - binocular

  3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.

Other Outcomes (3)

• Intraocular pressure (IOP) measurement

  Pre-OP, 1 day postoperative, 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.

• Keratometry

  Pre-OP

• Biometry

  Pre-OP

Study Arms (2)

IOL implantation experimental

EXPERIMENTAL

hydrophobic, trifocal intraocular lens POD F GF

Device: IOL implantation experimental

IOL implantation active comparator

ACTIVE COMPARATOR

hydrophilic, trifocal intraocular lens POD F

Device: IOL implantation active comparator

Interventions

IOL implantation experimental DEVICE

Implantation of trifocal IOL POD F GF consisting of hydrophobic material

IOL implantation experimental

IOL implantation active comparator DEVICE

Implantation of trifocal IOL POD F consisting of hydrophilic material

IOL implantation active comparator

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Unrealistic expectation
• Age of patient \<45 years
• Irregular astigmatism
• Regular corneal astigmatism \>0.75 dioptres by an automatic keratometer or biometer or \>1.0 dioptres if the steep axis of cylinder is between 90° and 120°
• 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)
• Age-related Macular Degeneration (AMD) suspicious eyes (determined by OCT)
• Complicated surgery

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: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2017
• First Posted: October 11, 2017
• Study Start: December 4, 2017
• Primary Completion: January 24, 2019
• Study Completion: February 10, 2022
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

PH (1)