Back to resultsRotational Stability of V4C Toric Implantable Contact Lenses After On Axis Implantation Measured With OPD Scan 3
Primary Purpose
Myopic Astigmatism
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
V4c toric ICL implantation surgery
Sponsored by
About this trial
This is an interventional treatment trial for Myopic Astigmatism
Eligibility Criteria
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
Sites / Locations
- Department of Ophthalmology, Yonsei University College of MedicineRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
V4c toric ICL implantation Group
Arm Description
V4c toric ICL implantation Group
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03391544
Brief Title
Rotational Stability of V4C Toric Implantable Contact Lenses After On Axis Implantation Measured With OPD Scan 3
Official Title
Rotational Stability of V4C Toric Implantable Contact Lenses After On Axis Implantation Measured With OPD Scan 3
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 28, 2017 (Actual)
Primary Completion Date
April 2018 (Anticipated)
Study Completion Date
April 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopic Astigmatism
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
V4c toric ICL implantation Group
Arm Type
Experimental
Arm Description
V4c toric ICL implantation Group
Intervention Type
Procedure
Intervention Name(s)
V4c toric ICL implantation surgery
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual outcome
Description
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.
Time Frame
6 months after the surgery
Title
Refractive outcome
Description
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.
Time Frame
6 months after the surgery
Secondary Outcome Measure Information:
Title
Rotational stability
Description
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.
Time Frame
immediately after the surgery
Title
Rotational stability
Description
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.
Time Frame
3 months after the surgery
Title
Rotational stability
Description
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.
Time Frame
6 months after the surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Ophthalmology, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tae-im Kim, MD, Ph.D
Phone
2-2-2228-3570
Email
tikim@yuhs.ac
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Rotational Stability of V4C Toric Implantable Contact Lenses After On Axis Implantation Measured With OPD Scan 3
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