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

Astigmatism Clinical Trial

— HIPER-AT-TORBI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05058274
• Other study ID #: HIPER-AT-TORBI
• Status: Completed
• Start date: November 3, 2021
• Est. completion date: February 21, 2024

Study information

• Verified date: March 2024
• Source: OFTALVIST (Oftalmología Vistahermosa S.L)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 21, 2024
• Est. primary completion date: February 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Astigmatism
• Cataract
• Cataracts
• Hyperopia

Intervention

Device:
• Implant of the AT-TORBI 709 lens
Implant of the AT-TORBI 709 lens

Locations

Country	Name	City	State
Spain	OFTALVIST (Oftalmología Vistahermosa S.L.)	Alicante
Spain	OFTALVIST (Oftalmología Vistahermosa S.L.)	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
OFTALVIST (Oftalmología Vistahermosa S.L)	Carl Zeiss Meditec AG

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Measurement of the rotational stability	Measurement of the rotational stability	12 months
Secondary	Measure of visual acuity	Measurement of visual acuity	12 months
Secondary	Measure of corneal topography	Measure of corneal topography	12 months
Secondary	Measure of ocular biometry	Measure of ocular biometry	12 months
Secondary	Measure of contrast sensitivity	Measure of contrast sensitivity	12 months
Secondary	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
Secondary	Slit lamp examination	Slit lamp examination	12 months