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.
Study Type
OBSERVATIONAL
Enrollment
60
Implant of the AT-TORBI 709 lens
OFTALVIST (Oftalmología Vistahermosa S.L.)
Alicante, Spain
OFTALVIST (Oftalmología Vistahermosa S.L.)
Valencia, Spain
Measurement of the refractive error
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
Measurement of the rotational stability
Time frame: 12 months
Measure of visual acuity
Measurement of visual acuity
Time frame: 12 months
Measure of corneal topography
Measure of corneal topography
Time frame: 12 months
Measure of ocular biometry
Measure of ocular biometry
Time frame: 12 months
Measure of contrast sensitivity
Measure of contrast sensitivity
Time frame: 12 months
Satisfaction questionaire
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
Slit lamp examination
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.