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OpenTrials
Completed

NCT Number: NCT05058274

Clinical Results of a Monofocal Aspheric Bitoric Intraocular Lens With Plate Haptics in Hyperopic Eyes (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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

OFTALVIST (Oftalmología Vistahermosa S.L.), Alicante, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients of 50 years of age or older to undergo cataract surgery with phacoemulsification
  • Patient who signs the informed consent.
  • Regular corneal astigmatism between 1.0D and 4.0D.
  • IOL power between 21D and 26D
  • Target-target distance measured with the IOLMaster 700 biometer (Carl Zeiss Meditec AG) greater than 11.6 mm.
  • Patients with hyperopia between 1.0D and 4.0D.

Exclusion criteria

  • Patients who do not provide informed consent
  • Patients who do not understand the study procedure
  • Previous corneal surgery.
  • Irregular cornea (eg keratoconus)
  • myopic patients
  • Eye abnormalities or pathologies that could reduce the visual function or stability of the IOL (eg severe amblyopia or macular degeneration)

Treatment and study plan

Implant of the AT-TORBI 709 lens

Device

Implant of the AT-TORBI 709 lens

Primary outcomes

  1. Measurement of the refractive error

    Time frame: 12 months

    Measurement of the refractive error (equivalent spherical error, the refractive cylinder and the astigmatism vectors (J0 and J45) )

  2. Measurement of the rotational stability

    Time frame: 12 months

    Measurement of the rotational stability

Secondary outcomes

  1. Measure of visual acuity

    Time frame: 12 months

    Measurement of visual acuity

  2. Measure of corneal topography

    Time frame: 12 months

    Measure of corneal topography

  3. Measure of ocular biometry

    Time frame: 12 months

    Measure of ocular biometry

  4. Measure of contrast sensitivity

    Time frame: 12 months

    Measure of contrast sensitivity

  5. Satisfaction questionaire

    Time frame: 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)

  6. Slit lamp examination

    Time frame: 12 months

    Slit lamp examination

Sponsors and collaborators

Lead sponsor

OFTALVIST (Oftalmología Vistahermosa S.L)

Industry

Collaborators

  • Carl Zeiss Meditec AG

Registry information

Acronym: HIPER-AT-TORBI

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Sep 27, 2021
Registry last updated
Mar 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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