Comparison Between TICL and ICL+AK for High Myopic Astigmatism

Not Applicable

Completed

• Conditions: Astigmatism; High Myopia
• Interventions: Device: Toric Implantable Collamer Lens; Device: ICL + Astigmatic keratotomy

• Registration Number: NCT03202485
• Lead Sponsor: Wenzhou Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-03
• Primary Completion: 2015-03-02
• Study Completion: 2017-01-01
• Status Verified: 2017-06
• Study First Submitted: 2017-06-22
• Study First Submitted QC: 2017-06-27
• Last Update Submitted: 2017-06-27
• Study First Posted: 2017-06-28
• Last Update Posted: 2017-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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.

Exclusion Criteria

• subjects had significant irregular astigmatism, corneal pathological changes, glaucoma, ocular inflammation, or previous ocular trauma or surgery.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Toric Implantable Collamer Lens	Toric Implantable Collamer Lens	Subjects in this group will implant Toric Implantable Collamer Lens for high myopic astigmatism
ICL+ Astigmatic keratotomy	ICL + Astigmatic keratotomy	Subjects in this group will implant Implantable Collamer Lens and combined with astigmatic keratotomy for high myopic astigmatism

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
mean postoperative UCVA/mean preoperative BCVA	2 years after surgery	efficacy index
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