Comparison Between TICL and ICL+AK for High Myopic Astigmatism

June 27, 2017 updated by: A-Yong Yu, Wenzhou Medical University

Comparison Between Toric and Spherical Implantable Collamer Lens Combined With Astigmatic Keratotomy 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Toric Implantable Collamer Lens
Subjects in this group will implant Toric Implantable Collamer Lens for high myopic astigmatism
Device: Toric Implantable Collamer Lens
uses Toric Implantable Collamer Lens implantation to correct the high myopic astigmatism.
Experimental: ICL+ Astigmatic keratotomy
Subjects in this group will implant Implantable Collamer Lens and combined with astigmatic keratotomy for high myopic astigmatism
Device: ICL + Astigmatic keratotomy
uses Implantable Collamer Lens implantation combined with Astigmatic keratotomy to correct the high myopic astigmatism

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uncorrected Visual Acuity (UCVA) at distance
Time Frame: 2 years after surgery
measured at 5 meter
2 years after surgery
astigmatism
Time Frame: 2 years after surgery
astigmatism getting from subjective refraction
2 years after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best Corrected Visual Acuity (BCVA) at distance
Time Frame: 2 years after surgery
subjective refraction
2 years after surgery
Spherical Equivalent (SE)
Time Frame: 2 years after surgery
subjective refraction
2 years after surgery
mean postoperative BCVA/mean preoperative BCVA
Time Frame: 2 years after surgery
safety index
2 years after surgery
mean postoperative UCVA/mean preoperative BCVA
Time Frame: 2 years after surgery
efficacy index
2 years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wenzhou Medical University

Investigators

  • Principal Investigator: AYong Yu, MD.PhD., Wenzhou Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2014

Primary Completion (Actual)

March 2, 2015

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

June 22, 2017

First Submitted That Met QC Criteria

June 27, 2017

First Posted (Actual)

June 28, 2017

Study Record Updates

Last Update Posted (Actual)

June 28, 2017

Last Update Submitted That Met QC Criteria

June 27, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TICL compare with ICL+AK

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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