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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-28

Study Completion Date

2018-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Myopic Astigmatism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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V4c toric ICL implantation Group

Group Type EXPERIMENTAL

V4c toric ICL implantation surgery

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No