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

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.

Study Overview

• Status: Completed
• Conditions: Astigmatism; Cataracts; Far Sightedness
• Intervention / Treatment: Device: Implant of the AT-TORBI 709 lens

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 Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Spain
  • Alicante, Spain, 03015
    • OFTALVIST (Oftalmología Vistahermosa S.L.)
  • Valencia, Spain, 46004
    • OFTALVIST (Oftalmología Vistahermosa S.L.)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Single arm; All participants	Device: Implant of the AT-TORBI 709 lens; Implant of the AT-TORBI 709 lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of the refractive error	Measurement of the refractive error (equivalent spherical error, the refractive cylinder and the astigmatism vectors (J0 and J45) )	12 months
Measurement of the rotational stability	Measurement of the rotational stability	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure of visual acuity	Measurement of visual acuity	12 months
Measure of corneal topography	Measure of corneal topography	12 months
Measure of ocular biometry	Measure of ocular biometry	12 months
Measure of contrast sensitivity	Measure of contrast sensitivity	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)	12 months
Slit lamp examination	Slit lamp examination	12 months

Collaborators and Investigators

• Sponsor: OFTALVIST (Oftalmología Vistahermosa S.L)
• Collaborators: Carl Zeiss Meditec AG
• Investigators: Principal Investigator: Pedro Tañá Rivero, Doctor, OFTALVIST (Oftalmología Vistahermosa S.L)

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2021
• Primary Completion (Actual): February 21, 2024
• Study Completion (Actual): February 21, 2024

Study Registration Dates

• First Submitted: September 8, 2021
• First Submitted That Met QC Criteria: September 17, 2021
• First Posted (Actual): September 27, 2021

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Refractive Errors; Cataract; Astigmatism; Hyperopia
• Other Study ID Numbers: HIPER-AT-TORBI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: A publication summarizing the results of the study will be made public after the study termination.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No