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OpenTrials
Completed

NCT Number: NCT03202485

Comparison Between TICL and ICL+AK for High Myopic Astigmatism

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.

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Key information

Conditions

Astigmatism Eye Diseases High Myopia Refractive Errors

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Toric Implantable Collamer Lens

Device

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

ICL + Astigmatic keratotomy

Device

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

Primary outcomes

  1. Uncorrected Visual Acuity (UCVA) at distance

    Time frame: 2 years after surgery

    measured at 5 meter

  2. astigmatism

    Time frame: 2 years after surgery

    astigmatism getting from subjective refraction

Secondary outcomes

  1. Best Corrected Visual Acuity (BCVA) at distance

    Time frame: 2 years after surgery

    subjective refraction

  2. Spherical Equivalent (SE)

    Time frame: 2 years after surgery

    subjective refraction

  3. mean postoperative BCVA/mean preoperative BCVA

    Time frame: 2 years after surgery

    safety index

  4. mean postoperative UCVA/mean preoperative BCVA

    Time frame: 2 years after surgery

    efficacy index

Sponsors and collaborators

Lead sponsor

Wenzhou Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2017
First posted
Jun 28, 2017
Registry last updated
Jun 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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