PHY2013: Rotational Stability Analysis of a Toric Monofocal IOL

Sponsor
Beaver-Visitec International, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04933487
Collaborator
targomedGmbH (Industry)
23
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54.1
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Study Details

Study Description

Brief Summary

This is a single-center, prospective PMCF study whereby patients undergoing routine cataract surgery will have monolateral implantation of hydrophilic monofocal toric intraocular lens Ankoris.

Condition or Disease Intervention/Treatment Phase
  • Device: IOL implantation experimental
N/A

Detailed Description

This is a single-center, prospective, nonrandomized PMCF study whereby patients undergoing routine cataract surgery will have monolateral implantation of hydrophilic monofocal toric intraocular lens (Ankoris). The device under investigation is manufactured by the sponsor of this study. The refractive power of the lens has a spherical and a cylindrical component. The IOLs will be implanted in the course of routine cataract surgery and will benefit to patients suffering from cataract development and showing pre-existing corneal astigmatism.

The primary objective of this study is to determine the rotational stability of the Ankoris intraocular lens. The secondary objective is to measure the residual astigmatism after Ankoris implantation with respect to the targeted astigmatism correction.

In total approx. 20 eyes of 20 patients will be recruited for this clinical study.

Follow-ups will be performed 1 day, 1 month, and 3 months after cataract surgery. Subjects would have the option for unscheduled visits if required medically.

Study Design

Study Type:
Interventional
Actual Enrollment :
23 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Prospective Evaluation of the Rotational Stability of the Ankoris Intraocular Lens
Actual Study Start Date :
Aug 26, 2014
Actual Primary Completion Date :
Jan 1, 2016
Actual Study Completion Date :
Mar 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ankoris IOL Implantation experimental

Monolateral implantation of toric intraocular lenses Ankoris

Device: IOL implantation experimental
Monolateral implantation of toric intraocular lenses Ankoris. (Manufactured by PhysIOL sa/nv, Liège, Belgium).

Outcome Measures

Primary Outcome Measures

  1. Rotational stability - Photograph of IOL with dilated pupil to asses IOL rotation [3 months postoperative]

    Rotational stability of the ANKORIS is evaluated on the basis of slit-lamp photographies to capture the iris and the marks onto the lens. Descriptive statistics will be used to determine the IOL stability.

Secondary Outcome Measures

  1. Residual astigmatism after Ankoris implantation with respect to the targeted astigmatism correction. [Follow-ups will be performed 1 day, 1 month, and 3 months after cataract surgery]

    Visual performance is determined in terms of monocular uncorrected distance visual acuity (UDVA), distance corrected visual acuity (DCVA) and postoperative refraction. Efficiency will be assessed using Alpins method.

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Cataracteous Eyes with no comorbidity

  • Regular corneal astigmatism >1 dioptre and <3D determined by an automatic keratometer (regularity determined by the topography of the keratometry).

  • Availability, willingness and sufficient cognitive awareness to comply with examination procedures

  • Signed informed consent •>50 years old

Exclusion Criteria:
  • Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc…)

  • Any ocular comorbidity

  • History of ocular trauma or prior ocular surgery including refractive procedures

  • Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, Marfan's syndrome)

  • Pupil abnormalitis (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ruhr-Universitat Bochum, Bochum, Germany Bochum Germany

Sponsors and Collaborators

  • Beaver-Visitec International, Inc.
  • targomedGmbH

Investigators

  • Principal Investigator: Burkhard Dick, MD, Ruhr-Universitat Bochum, Bochum, Germany

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Beaver-Visitec International, Inc.
ClinicalTrials.gov Identifier:
NCT04933487
Other Study ID Numbers:
  • PHY2013
First Posted:
Jun 21, 2021
Last Update Posted:
Jun 21, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Beaver-Visitec International, Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 21, 2021