NCT03202485

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2014

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 3, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2015

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 28, 2017

Completed
Last Updated

June 28, 2017

Status Verified

June 1, 2017

Enrollment Period

12 months

First QC Date

June 22, 2017

Last Update Submit

June 27, 2017

Conditions

AstigmatismHigh Myopia

Keywords

astigmatismhigh myopiaphakic intraocular lensastigmatic keratotomytoric

Outcome Measures

Primary Outcomes (2)

  • Uncorrected Visual Acuity (UCVA) at distance

    measured at 5 meter

    2 years after surgery

  • astigmatism

    astigmatism getting from subjective refraction

    2 years after surgery

Secondary Outcomes (4)

  • Best Corrected Visual Acuity (BCVA) at distance

    2 years after surgery

  • Spherical Equivalent (SE)

    2 years after surgery

  • mean postoperative BCVA/mean preoperative BCVA

    2 years after surgery

  • mean postoperative UCVA/mean preoperative BCVA

    2 years after surgery

Study Arms (2)

Toric Implantable Collamer Lens

ACTIVE COMPARATOR

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

Device: Toric Implantable Collamer Lens

ICL+ Astigmatic keratotomy

EXPERIMENTAL

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

Device: ICL + Astigmatic keratotomy

Interventions

Toric Implantable Collamer LensDEVICE

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

Toric Implantable Collamer Lens
ICL + Astigmatic keratotomyDEVICE

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

ICL+ Astigmatic keratotomy

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 28828390DERIVED

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • AYong Yu, MD.PhD.

    Wenzhou Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective comparative case series
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
vice director of refractive surgery department of the eye hospital of WZMU

Study Record Dates

First Submitted

June 22, 2017

First Posted

June 28, 2017

Study Start

March 3, 2014

Primary Completion

March 2, 2015

Study Completion

January 1, 2017

Last Updated

June 28, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share