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

Not Applicable

• Conditions: Myopic Astigmatism
• Interventions: Procedure: V4c toric ICL implantation surgery

• Registration Number: NCT03391544
• Lead Sponsor: Yonsei University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-28
• Status Verified: 2017-12
• Study First Submitted: 2017-12-21
• Study First Submitted QC: 2017-12-28
• Last Update Submitted: 2018-01-04
• Study First Posted: 2018-01-05
• Last Update Posted: 2018-01-08
• Primary Completion: 2018-04
• Study Completion: 2018-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
V4c toric ICL implantation Group	V4c toric ICL implantation surgery	V4c toric ICL implantation Group

Primary Outcome Measures

Name	Time	Method
Visual outcome	6 months after the surgery	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.
Refractive outcome	6 months after the surgery	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.

Secondary Outcome Measures

Name	Time	Method
Rotational stability	6 months after the surgery	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.

Trial Locations

Locations (1)

Department of Ophthalmology, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of