Comparison Between TICL and ICL+AK for High Myopic Astigmatism

Sponsor

Wenzhou Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT03202485

Collaborator

(none)

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

Brief Summary

To compare the outcomes of a toric Implantable Collamer Lens (ICL) and a spherical Implantable Collamer Lens combined with astigmatic keratotomy (AK) in the correction of high myopic astigmatism.

Condition or Disease	Intervention/Treatment	Phase
Astigmatism High Myopia	Device: Toric Implantable Collamer Lens Device: ICL + Astigmatic keratotomy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

62 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Prospective comparative case seriesProspective comparative case series

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Comparison Between Toric and Spherical Implantable Collamer Lens Combined With Astigmatic Keratotomy for High Myopic Astigmatism

Actual Study Start Date :

Mar 3, 2014

Actual Primary Completion Date :

Mar 2, 2015

Actual Study Completion Date :

Jan 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Toric Implantable Collamer Lens Subjects in this group will implant Toric Implantable Collamer Lens for high myopic astigmatism	Device: Toric Implantable Collamer Lens uses Toric Implantable Collamer Lens implantation to correct the high myopic astigmatism.
Experimental: ICL+ Astigmatic keratotomy Subjects in this group will implant Implantable Collamer Lens and combined with astigmatic keratotomy for high myopic astigmatism	Device: ICL + Astigmatic keratotomy uses Implantable Collamer Lens implantation combined with Astigmatic keratotomy to correct the high myopic astigmatism

Arm

Intervention/Treatment

Active Comparator: Toric Implantable Collamer Lens

Subjects in this group will implant Toric Implantable Collamer Lens for high myopic astigmatism

Device: Toric Implantable Collamer Lens

uses Toric Implantable Collamer Lens implantation to correct the high myopic astigmatism.

Experimental: ICL+ Astigmatic keratotomy

Subjects in this group will implant Implantable Collamer Lens and combined with astigmatic keratotomy for high myopic astigmatism

Device: ICL + Astigmatic keratotomy

uses Implantable Collamer Lens implantation combined with Astigmatic keratotomy to correct the high myopic astigmatism

Outcome Measures

Primary Outcome Measures

Uncorrected Visual Acuity (UCVA) at distance [2 years after surgery]
measured at 5 meter
astigmatism [2 years after surgery]
astigmatism getting from subjective refraction

Secondary Outcome Measures

Best Corrected Visual Acuity (BCVA) at distance [2 years after surgery]
subjective refraction
Spherical Equivalent (SE) [2 years after surgery]
subjective refraction
mean postoperative BCVA/mean preoperative BCVA [2 years after surgery]
safety index
mean postoperative UCVA/mean preoperative BCVA [2 years after surgery]
efficacy index

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

age ranged from 18 to 40 years,
myopia greater than -8.00 diopters (D), and refractive cylinder in the range of 1.50D to 5.50D,
for the patients who were planned to undergo AK+ICL implantation, the axial difference between the corneal astigmatism and the manifest refractive astigmatism was less than 10 degree,
a stable refractive error during the previous 2 years,
anterior chamber depth more than 2.8 mm,
endothelial cell density (ECD) more than 2500 cells/mm2, and
scotopic pupillary diameter less than 7 mm.