Comparison Between a Toric Monofocal and Multifocal Intraocular Lens

NCT04907318 | Completed

• 1 other identifier: PHY PODT-POD FT
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the study is to observe the rotational stability of the implant 30 minutes, one day, 6 weeks, 6 months and 12 months after the implant surgery. In addition, the refraction will be measured as it is directly affected in the event of postoperative rotation. The correlation between postoperative rotation and the following parameters will be determined: PEXS, white-to-white, age, axial length, anterior chamber depth. Visual acuities with and without correction and the best refraction to assess the benefit of the implants will also be investigated.

Conditions

Cataract

Keywords

IOL; Toric; Multifocal

Outcome Measures

Primary Outcomes (1)

• To observe the rotational stability of the implant

  Observation of rotational stability of the implant

  6 Months

Secondary Outcomes (1)

• Visual Acuity

  6 Months

Study Arms (2)

ANKORIS

Cataract surgery performed with POD26PAYT

Device: Cataract surgery

FINEVISION TORIC

Cataract surgery performed with POD26PAYFT

Device: Cataract surgery

Interventions

Cataract surgery DEVICE

ANKORIS; FINEVISION TORIC

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This retrospective study will include approximately 90 eyes of patients (adults) receiving conventional cataract surgery having a preoperative corneal astigmatism of 1.0 D or higher and had been implanted with the Ankoris or T-Flex or FineVision toric implant (about 30/30 and20). So that the groups are comparable, the inclusion and exclusion criteria will be those applicable to a multifocal implant.

You may qualify if:

• Cataract (with or without presbyopia)
• No pre-existing ocular pathology or history of ocular surgery
• No phacodonesis
• PEX patients (pseudoexfoliation syndrome) can be included.

You may not qualify if:

• To ensure equivalence of the two comparable groups, the patients with potential postoperative visual acuity less than 5/10, particularly due to an insufficient retinal function or poor corneal condition will be excluded.
• In particular the patients with the following pathologies will be excluded:
• Irregular astigmatism.
• Cases of uncontrolled glaucoma.
• Intraocular inflammation.
• Narrow anterior chambers (2.5 mm).
• Amblyopia with potential visual acuity less than 5/10.
• Any corneal pathology potentially affecting topography (e.g., keratoconus).
• Patients with a history of corneal surgery (especially refractive surgery).
• Patients with diagnosed degenerative visual disorders (e.g., macular degeneration, diabetic retinopathy or other retina diseases or surgery) with known negative impact on visual function possibly leading to visual acuity levels below 0.5.
• Patients with a history of ocular trauma.
• Pathological miosis.
• Patients with zonular laxity.
• Patients suffering from chronic uveitis.

Sponsors & Collaborators

• Beaver-Visitec International, Inc.: lead

Study Sites (1)

Vista Alpina Eye Center

Visp, 3930, Switzerland

Location

MeSH Terms

Conditions

Cataract

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Kristof Vandekerckhove, MD

  Vista Alpina Eye Cente, Visp, Switzerland, 3930

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: May 28, 2021
• Study Start: January 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: July 1, 2016
• Last Updated: June 2, 2021

Record last verified: 2021-05

Locations

CH (1)