Comparison Between TICL and ICL+AK for High Myopic Astigmatism

NCT ID: NCT03202485

Last Updated: 2017-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-03

Study Completion Date

2017-01-01

Brief Summary

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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

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Conditions

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Astigmatism High Myopia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Prospective comparative case series
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Toric Implantable Collamer Lens

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

Group Type ACTIVE_COMPARATOR

Toric Implantable Collamer Lens

Intervention Type DEVICE

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

ICL+ Astigmatic keratotomy

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

Group Type EXPERIMENTAL

ICL + Astigmatic keratotomy

Intervention Type DEVICE

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

Interventions

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Toric Implantable Collamer Lens

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

Intervention Type DEVICE

ICL + Astigmatic keratotomy

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wenzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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A-Yong Yu

vice director of refractive surgery department of the eye hospital of WZMU

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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AYong Yu, MD.PhD.

Role: PRINCIPAL_INVESTIGATOR

Wenzhou Medical University

References

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Zheng LY, Zhu SQ, Su YF, Zou HY, Wang QM, Yu AY. Comparison between toric and spherical phakic intraocular lenses combined with astigmatic keratotomy for high myopic astigmatism. Eye Vis (Lond). 2017 Aug 18;4:20. doi: 10.1186/s40662-017-0085-7. eCollection 2017.

Reference Type DERIVED
PMID: 28828390 (View on PubMed)

Other Identifiers

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TICL compare with ICL+AK

Identifier Type: -

Identifier Source: org_study_id

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