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

Completed

• Conditions: Astigmatism; Cataracts; Far Sightedness
• Interventions: Device: Implant of the AT-TORBI 709 lens

• Registration Number: NCT05058274
• Lead Sponsor: OFTALVIST (Oftalmología Vistahermosa S.L)

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.

Study Timeline

• Study First Submitted: 2021-09-08
• Study First Submitted QC: 2021-09-17
• Study First Posted: 2021-09-27
• Study Start: 2021-11-03
• Primary Completion: 2024-02-21
• Study Completion: 2024-02-21
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-21
• Last Update Posted: 2024-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Single arm	Implant of the AT-TORBI 709 lens	All participants

Primary Outcome Measures

Name	Time	Method
Measurement of the refractive error	12 months	Measurement of the refractive error (equivalent spherical error, the refractive cylinder and the astigmatism vectors (J0 and J45) )
Measurement of the rotational stability	12 months	Measurement of the rotational stability

Secondary Outcome Measures

Name	Time	Method
Measure of visual acuity	12 months	Measurement of visual acuity
Measure of corneal topography	12 months	Measure of corneal topography
Measure of ocular biometry	12 months	Measure of ocular biometry
Measure of contrast sensitivity	12 months	Measure of contrast sensitivity
Satisfaction questionaire	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)
Slit lamp examination	12 months	Slit lamp examination

Trial Locations

Locations (1)

OFTALVIST (Oftalmología Vistahermosa S.L.); 🇪🇸 Valencia, Spain