Rotational Stability Analysis of a Toric Monofocal IOL

Cataract Clinical Trial

— PHY2013  

Official title:

Prospective Evaluation of the Rotational Stability of the Ankoris Intraocular Lens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04933487
• Other study ID #: PHY2013
• Status: Completed
• Phase: N/A
• Start date: August 26, 2014
• Est. completion date: March 2019

Study information

• Verified date: June 2021
• Source: Beaver-Visitec International, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: March 2019
• Est. primary completion date: January 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Astigmatism
• Cataract
• Lens Opacities

Intervention

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

Locations

Country	Name	City	State
Germany	Ruhr-Universitat Bochum, Bochum, Germany	Bochum

Sponsors (2)

Lead Sponsor	Collaborator
Beaver-Visitec International, Inc.	targomedGmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rotational stability - Photograph of IOL with dilated pupil to asses IOL rotation	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.	3 months postoperative
Secondary	Residual astigmatism after Ankoris implantation with respect to the targeted astigmatism correction.	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.	Follow-ups will be performed 1 day, 1 month, and 3 months after cataract surgery