Comparison Between TICL and ICL+AK for High Myopic Astigmatism

Wenzhou Medical University

Status: Completed

Conditions: Astigmatism; High Myopia

Treatments: Device: Toric Implantable Collamer Lens; Device: ICL + Astigmatic keratotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03202485

TICL compare with ICL+AK

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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62 participants in 2 patient groups

Toric Implantable Collamer Lens

Active Comparator group

Description:

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

Treatment:

Device: Toric Implantable Collamer Lens

ICL+ Astigmatic keratotomy

Experimental group

Description:

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

Treatment:

Device: ICL + Astigmatic keratotomy