Clinical Results of a Monofocal Aspheric Bitoric Intraocular Lens With Plate Haptics in Hyperopic Eyes (HIPER-AT-TORBI)

NCT05058274 | Completed

• 1 other identifier: HIPER-AT-TORBI
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

Observational post-marketing study with prospective follow-up of CE marked medical devices aimed at the treatment of hyperopia and astigmatism in patients with cataract. The objective is to evaluate the clinical results of the implantation of the monofocal aspheric bitoric intraocular lens (IOL) with AT-TORBI 709 plate haptics in cataract surgery of hyperopic eyes with astigmatism.

Conditions

Astigmatism; Far Sightedness; Cataracts

Outcome Measures

Primary Outcomes (2)

• Measurement of the refractive error

  Measurement of the refractive error (equivalent spherical error, the refractive cylinder and the astigmatism vectors (J0 and J45) )

  12 months

• Measurement of the rotational stability

  Measurement of the rotational stability

  12 months

Secondary Outcomes (6)

• Measure of visual acuity

  12 months

• Measure of corneal topography

  12 months

• Measure of ocular biometry

  12 months

• Measure of contrast sensitivity

  12 months

• Satisfaction questionaire

  12 months

Study Arms (1)

Single arm

All participants

Device: Implant of the AT-TORBI 709 lens

Interventions

Implant of the AT-TORBI 709 lens DEVICE

Implant of the AT-TORBI 709 lens

Single arm

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are going to undergo conventional cataract surgery by phacoemulsification following regular clinical practice and present hyperopia with astigmatism.

You may qualify if:

• Patients of 50 years of age or older to undergo cataract surgery with phacoemulsification
• Patient who signs the informed consent.
• Regular corneal astigmatism between 1.0D and 4.0D.
• IOL power between 21D and 26D
• Target-target distance measured with the IOLMaster 700 biometer (Carl Zeiss Meditec AG) greater than 11.6 mm.
• Patients with hyperopia between 1.0D and 4.0D.

You may not qualify if:

• Patients who do not provide informed consent
• Patients who do not understand the study procedure
• Previous corneal surgery.
• Irregular cornea (eg keratoconus)
• myopic patients
• Eye abnormalities or pathologies that could reduce the visual function or stability of the IOL (eg severe amblyopia or macular degeneration)

Sponsors & Collaborators

• OFTALVIST (Oftalmología Vistahermosa S.L): lead
• Carl Zeiss Meditec AG: collaborator

Study Sites (2)

OFTALVIST (Oftalmología Vistahermosa S.L.)

Alicante, 03015, Spain

Location

OFTALVIST (Oftalmología Vistahermosa S.L.)

Valencia, 46004, Spain

Location

MeSH Terms

Conditions

Astigmatism; Hyperopia; Cataract

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases; Lens Diseases

Study Officials

• Pedro Tañá Rivero, Doctor

  OFTALVIST (Oftalmología Vistahermosa S.L)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: September 27, 2021
• Study Start: November 3, 2021
• Primary Completion: February 21, 2024
• Study Completion: February 21, 2024
• Last Updated: March 22, 2024

Record last verified: 2024-03

Locations

ES (2)