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

Yonsei University

Status: Unknown

Conditions: Myopic Astigmatism

Treatments: Procedure: V4c toric ICL implantation surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT03391544

4-2017-0243

Details and patient eligibility

About

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.

Enrollment: 75 estimated patients

Sex: All

Ages: 19 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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75 participants in 1 patient group

V4c toric ICL implantation Group

Experimental group

Description:

V4c toric ICL implantation Group

Treatment:

Procedure: V4c toric ICL implantation surgery