Implant of the AT-TORBI 709 lens
DeviceImplant of the AT-TORBI 709 lens
NCT Number: NCT05058274
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.
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Notify Me50 year and older
All sexes
Observational
OFTALVIST (Oftalmología Vistahermosa S.L.), Alicante, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Implant of the AT-TORBI 709 lens
Time frame: 12 months
Measurement of the refractive error (equivalent spherical error, the refractive cylinder and the astigmatism vectors (J0 and J45) )
Time frame: 12 months
Measurement of the rotational stability
Time frame: 12 months
Measurement of visual acuity
Time frame: 12 months
Measure of corneal topography
Time frame: 12 months
Measure of ocular biometry
Time frame: 12 months
Measure of contrast sensitivity
Time frame: 12 months
For several questions percentage of respondants answering each of five possible provided answers ranging progressively from strong disatisfaction to strong satisfaction (1-4) as well as an answer for those patients who cannot decide (5)
Time frame: 12 months
Slit lamp examination
OFTALVIST (Oftalmología Vistahermosa S.L)
Industry
Acronym: HIPER-AT-TORBI
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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