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

OFTALVIST (Oftalmología Vistahermosa S.L)

Status: Completed

Conditions: Far Sightedness; Astigmatism; Cataracts

Treatments: Device: Implant of the AT-TORBI 709 lens

Study type: Observational

Funder types: Industry

Identifiers

NCT05058274

HIPER-AT-TORBI

Details and patient eligibility

About

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.

Full description

All patients participating in the study will have the intraocular lens (IOL) AT TORBI 709 implanted from Carl Zeiss Meditec AG, Jena, Germany, with CE marking. All patients will be treated according to standard clinical practice. A preoperative and postoperative evaluation will be carried out one month, six and twelve months after the intervention where the following tests will be performed: refraction, corneal topography, measurement of visual acuity with and without correction, slit lamp examination, eye biometry using the IOLMaster 700 Carl Zeiss Meditec AG, Jena, Germany, CE marked optical non-contact biometer, contrast sensitivity with the CC-100 screen (Topcon Europe, The Netherlands), and the Catquest-9SF (European Registry of Quality Outcomes for Cataract and Refractive Surgery, founded by the European Society of Cataract and Refractive Surgeons). The sponsor has received an unrestricted research grant by Zeiss.

Enrollment: 60 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

60 participants in 1 patient group

Single arm

Description:

All participants

Treatment:

Device: Implant of the AT-TORBI 709 lens