Comparison Between TICL and ICL+AK for High Myopic Astigmatism

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03202485

Enrollment

Registered

2017-06-28

Start date

2014-03-03

Completion date

2017-01-01

Last updated

2017-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Astigmatism, High Myopia

Keywords

astigmatism, high myopia, phakic intraocular lens, astigmatic keratotomy, toric

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.

Interventions

DEVICEToric Implantable Collamer Lens

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

DEVICEICL + Astigmatic keratotomy

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Intervention model description

Prospective comparative case series

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

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.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026