Rotational Stability of V4C Toric Implantable Contact Lenses After On Axis Implantation Measured With OPD Scan 3

The recently introduced toric V4c toric ICL (STAAR Surgical Company, Monrovia, CA, USA) has been designed with a 360-µm central hole to allow aqueous humor to flow without the need for an iridotomy. As far as the investigators certain, there have been not well-established prospective studies on the role of the V4c toric ICL for myopic astigmatism correction. Therefore, the present study aimed to investigate the clinical outcomes and rotational stability and to analyze factors that influence the rotational stability in V4c toric ICL implanted eyes prospectively.

Study Overview

• Status: Unknown
• Conditions: Myopic Astigmatism
• Intervention / Treatment: Procedure: V4c toric ICL implantation surgery

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Recruiting
    • Department of Ophthalmology, Yonsei University College of Medicine
    • Contact: Tae-im Kim, MD, Ph.D; Phone Number: 2-2-2228-3570; Email: tikim@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 19-45 years
• Presence of myopia with a manifest refraction spherical equivalent between -5.00 and -20.00 diopters (D)
• Astigmatism between -0.75 and -5.00 D

Exclusion Criteria:

• Previous ocular or intraocular surgery (other than ICL implant)
• Anterior chamber depth from the endothelium < 2.8 mm
• Corneal endothelial cell density < 2000 cells/mm2
• Evidence of acute or chronic corneal infection, corneal inflammation
• Glaucoma, amblyopia, retinal detachment, diabetic retinopathy, macular degeneration, or neuro-ophthalmic disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: V4c toric ICL implantation Group

Procedure: V4c toric ICL implantation surgery; The size and power of the V4c toric ICL were determined following the manufacturer's guidelines using a modified vertex formula. Emmetropia was the target refraction following surgery in all cases. Before surgery, three centration points were marked using the slit lamp while the patient, in sitting position, fixated on the center of the slit-lamp beam, which was narrowed as much as possible.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual outcome	Evaluation of logarithm of the minimum angle of resolution (logMAR) uncorrected distance visual acuity (UDVA) and CDVA, manifest refraction, autorefractor-keratometer (ARK-530A; Nidek Co., Ltd.). The change of astigmatism was analyzed by the Alpins method.	6 months after the surgery
Refractive outcome	Evaluation of logarithm of the minimum angle of resolution (logMAR) uncorrected distance visual acuity (UDVA) and CDVA, manifest refraction, autorefractor-keratometer (ARK-530A; Nidek Co., Ltd.). The change of astigmatism was analyzed by the Alpins method.	6 months after the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rotational stability	Rotational stability of the toric ICL was measured using the OPD-Scan III (NIDEK Co. Ltd., Gamagori, Japan). The rotation was defined as the difference between the intended axis and the achieved axis at each follow-up. Assuming that the adjusted axis was identical to the intended angle, postoperative rotation was automatically measured by determining the angle between the adjusted axis and alignment axis. Each measurement was performed three times by one physician, and the average of the three measurements was used in the analysis.	immediately after the surgery
Rotational stability	Rotational stability of the toric ICL was measured using the OPD-Scan III (NIDEK Co. Ltd., Gamagori, Japan). The rotation was defined as the difference between the intended axis and the achieved axis at each follow-up. Assuming that the adjusted axis was identical to the intended angle, postoperative rotation was automatically measured by determining the angle between the adjusted axis and alignment axis. Each measurement was performed three times by one physician, and the average of the three measurements was used in the analysis.	3 months after the surgery
Rotational stability	Rotational stability of the toric ICL was measured using the OPD-Scan III (NIDEK Co. Ltd., Gamagori, Japan). The rotation was defined as the difference between the intended axis and the achieved axis at each follow-up. Assuming that the adjusted axis was identical to the intended angle, postoperative rotation was automatically measured by determining the angle between the adjusted axis and alignment axis. Each measurement was performed three times by one physician, and the average of the three measurements was used in the analysis.	6 months after the surgery

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2017
• Primary Completion (Anticipated): April 1, 2018
• Study Completion (Anticipated): April 1, 2018

Study Registration Dates

• First Submitted: December 21, 2017
• First Submitted That Met QC Criteria: December 28, 2017
• First Posted (Actual): January 5, 2018

Study Record Updates

• Last Update Posted (Actual): January 8, 2018
• Last Update Submitted That Met QC Criteria: January 4, 2018
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: 4-2017-0243

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No