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

NCT03391544 | Unknown

• 1 other identifier: 4-2017-0243
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopic Astigmatism

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Rotational stability

  immediately after the surgery

• Rotational stability

  3 months after the surgery

• Rotational stability

  6 months after the surgery

Study Arms (1)

V4c toric ICL implantation Group

EXPERIMENTAL

V4c toric ICL implantation Group

Procedure: V4c toric ICL implantation surgery

Interventions

V4c toric ICL implantation surgery 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.

V4c toric ICL implantation Group

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Ophthalmology, Yonsei University College of Medicine

Seoul, 03722, South Korea

RECRUITING

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2017
• First Posted: January 5, 2018
• Study Start: April 28, 2017
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: January 8, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)