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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.
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.
Age
50 - No limit years
Sex
ALL
Healthy Volunteers
No
OFTALVIST (Oftalmología Vistahermosa S.L.)
Alicante, Spain
OFTALVIST (Oftalmología Vistahermosa S.L.)
Valencia, Spain
Start Date
November 3, 2021
Primary Completion Date
February 21, 2024
Completion Date
February 21, 2024
Last Updated
March 22, 2024
60
ACTUAL participants
Implant of the AT-TORBI 709 lens
DEVICE
Lead Sponsor
OFTALVIST (Oftalmología Vistahermosa S.L)
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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View ClinicalTrials.gov Terms and ConditionsNCT07201298