Clinical trial NCT05058274: Clinical Results of a Monofocal Aspheric Bitoric Intraocular Lens With Plate Haptics in Hyperopic Eyes (HIPER-AT-TORBI)
Official title: Clinical Results of a Monofocal Aspheric Bitoric Intraocular Lens With Plate Haptics in Hyperopic Eyes (HIPER-AT-TORBI)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Astigmatism
Far Sightedness
Cataracts
Lead sponsor: OFTALVIST (Oftalmología Vistahermosa S.L)
Sponsor class: INDUSTRY
Collaborators: name: Carl Zeiss Meditec AG
First posted: 2021-09-27
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are going to undergo conventional cataract surgery by phacoemulsification following regular clinical practice and present hyperopia with astigmatism.

Brief 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Measurement of the refractive error
timeFrame: 12 months
measure: Measurement of the rotational stability
timeFrame: 12 months
Secondary outcomes:
measure: Measure of visual acuity
timeFrame: 12 months
measure: Measure of corneal topography
timeFrame: 12 months
measure: Measure of ocular biometry
timeFrame: 12 months
measure: Measure of contrast sensitivity
timeFrame: 12 months
measure: Satisfaction questionaire
timeFrame: 12 months
measure: Slit lamp examination
timeFrame: 12 months
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: OFTALVIST (Oftalmología Vistahermosa S.L.)
city: Valencia
country: Spain
facility: OFTALVIST (Oftalmología Vistahermosa S.L.)
Study officials:
affiliation: OFTALVIST (Oftalmología Vistahermosa S.L)
name: Pedro Tañá Rivero, Doctor
role: PRINCIPAL_INVESTIGATOR
References: