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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05058274
Other study ID # HIPER-AT-TORBI
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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