PHY2013: Rotational Stability Analysis of a Toric Monofocal IOL
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|
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.
Arms and Interventions
|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).
Primary Outcome Measures
- 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
- 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.
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
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
|1||Ruhr-Universitat Bochum, Bochum, Germany||Bochum||Germany|
Sponsors and Collaborators
- Beaver-Visitec International, Inc.
- Principal Investigator: Burkhard Dick, MD, Ruhr-Universitat Bochum, Bochum, Germany
Study Documents (Full-Text)None provided.