NCT01088568

Brief Summary

The objective is to conduct a contralateral prospective clinical study to compare the safety, efficacy, and quality of vision of the STAAR Surgical Co. Toric Implantable Contact Lens TICL) versus Custom Laser Vision Correction (Q-LASIK) in human eyes for the correction of myopia with astigmatism.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

November 1, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 17, 2010

Completed
Last Updated

March 17, 2010

Status Verified

October 1, 2009

Enrollment Period

1.1 years

First QC Date

March 16, 2010

Last Update Submit

March 16, 2010

Conditions

MyopiaAstigmatism

Keywords

Keratomileusis, laser in situPhakic Intraocular LensesmyopiaastigmatismImplantable Collamer Lens, Toric

Outcome Measures

Primary Outcomes (1)

  • Comparing the efficacy, predictability, stability and safety of TICL versus Q-LASIK

    1week, 1,3,6 months

Secondary Outcomes (1)

  • Comparing wavefront aberrometry of TICL vs Q-LASIK Comparing contrast sensitivity of TICL vs Q-LASIK Comparing patient satisfaction of TICL vs Q-LASIK

    1, 3, 6 months

Study Arms (2)

TICL group

EXPERIMENTAL
Procedure: the implantation of toric implantable collamer lens

LASIK group

ACTIVE COMPARATOR
Procedure: customized laser-assisted in situ keratomileusis

Interventions

the implantation of toric implantable collamer lensPROCEDURE

perform the implantation of toric implantable collamer lens for both eyes

Also known as: TICL
TICL group
customized laser-assisted in situ keratomileusisPROCEDURE

perform Q-factor customized laser-assisted in situ keratomileusis for both eyes

Also known as: Q-factor customized LASIK
LASIK group

Eligibility Criteria

Age21 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age: 21-45 years old
  • Documented stable refraction for at least 1 year
  • (-3.0 to -8.0D of myopia with -1.0 to -4.0D of astigmatism or SE from -3.5 to -10D
  • BSCVA: 20/20 or better
  • Pupil diameter: smaller than 7mm under mesopic condition
  • Contact lens discontinued 3 weeks and 1 week for hard and soft wearers respectively

You may not qualify if:

  • Evidence of progressive or acute disease
  • Evidence of connective tissue disease or clinically significant atopic disease
  • ACD less than 2.8mm from endothelium
  • ECC less than 2200 cells/mm2
  • Narrow angle of anterior chamber
  • Residual stromal thickness less than 280 microns

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eye hospital of Wenzhou Medical College

Wenzhou, Zhejiang, 325027, China

Location

Related Publications (3)

  • Sanders DR. Matched population comparison of the Visian Implantable Collamer Lens and standard LASIK for myopia of -3.00 to -7.88 diopters. J Refract Surg. 2007 Jun;23(6):537-53. doi: 10.3928/1081-597X-20070601-02.

    PMID: 17598571BACKGROUND

  • Sanders D, Vukich JA. Comparison of implantable collamer lens (ICL) and laser-assisted in situ keratomileusis (LASIK) for low myopia. Cornea. 2006 Dec;25(10):1139-46. doi: 10.1097/ICO.0b013e31802cbf3c.

    PMID: 17172886BACKGROUND

  • Sanders DR, Vukich JA. Comparison of implantable contact lens and laser assisted in situ keratomileusis for moderate to high myopia. Cornea. 2003 May;22(4):324-31. doi: 10.1097/00003226-200305000-00009.

    PMID: 12792475BACKGROUND

MeSH Terms

Conditions

MyopiaAstigmatism

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Qin Mei Wang

    Eye hospital of Wenzhou Medical College

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 16, 2010

First Posted

March 17, 2010

Study Start

November 1, 2007

Primary Completion

December 1, 2008

Study Completion

March 1, 2010

Last Updated

March 17, 2010

Record last verified: 2009-10

Locations

CN(1)