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

Sponsor
OFTALVIST (Oftalmología Vistahermosa S.L) (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05058274
Collaborator
Carl Zeiss Meditec AG (Industry)
60
Enrollment
2
Locations
7
Anticipated Duration (Months)
30
Patients Per Site
4.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Clinical Results of a Monofocal Aspheric Bitoric Intraocular Lens With Plate Haptics in Hyperopic Eyes (HIPER-AT-TORBI)
Actual Study Start Date :
Sep 30, 2021
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Apr 30, 2022

Arms and Interventions

ArmIntervention/Treatment
Single arm

All participants

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

Outcome Measures

Primary Outcome Measures

  1. 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) )

  2. Measurement of the rotational stability [12 months]

    Measurement of the rotational stability

Secondary Outcome Measures

  1. Measure of visual acuity [12 months]

    Measurement of visual acuity

  2. Measure of corneal topography [12 months]

    Measure of corneal topography

  3. Measure of ocular biometry [12 months]

    Measure of ocular biometry

  4. Measure of contrast sensitivity [12 months]

    Measure of contrast sensitivity

  5. 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)

  6. Slit lamp examination [12 months]

    Slit lamp examination

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1OFTALVIST (Oftalmología Vistahermosa S.L.)AlicanteSpain03015
2OFTALVIST (Oftalmología Vistahermosa S.L.)ValenciaSpain46004

Sponsors and Collaborators

  • OFTALVIST (Oftalmología Vistahermosa S.L)
  • Carl Zeiss Meditec AG

Investigators

  • Principal Investigator: Pedro Tañá Rivero, Doctor, OFTALVIST (Oftalmología Vistahermosa S.L)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
OFTALVIST (Oftalmología Vistahermosa S.L)
ClinicalTrials.gov Identifier:
NCT05058274
Other Study ID Numbers:
  • HIPER-AT-TORBI
First Posted:
Sep 27, 2021
Last Update Posted:
Oct 8, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 8, 2021