Clinical Trials Directory

Trials / Completed

CompletedNCT05058274

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

Status
Completed
Phase
—
Study type
Observational
Enrollment
60 (actual)
Sponsor
OFTALVIST (Oftalmología Vistahermosa S.L) · Industry
Sex
All
Age
50 Years
Healthy volunteers
Not accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
DEVICEImplant of the AT-TORBI 709 lensImplant of the AT-TORBI 709 lens

Timeline

Start date
2021-11-03
Primary completion
2024-02-21
Completion
2024-02-21
First posted
2021-09-27
Last updated
2024-03-22

Locations

2 sites across 1 country: Spain

Source: ClinicalTrials.gov record NCT05058274. Inclusion in this directory is not an endorsement.