Clinical Trials Logo
  1. Home
  2. Astigmatism
  3. NCT01680354
  4. Details
NCT01680354 Clinical Trial

Surgical Correction of Astigmatism

Astigmatism Clinical Trial

Official title:
Comparative Study of Surgical Laser Correction of Astigmatism

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01680354
Other study ID # AUH_ASTIGMATISM
Secondary ID
Status Withdrawn
Phase N/A
First received September 4, 2012
Last updated April 30, 2014
Start date September 2012

Study information
Verified date April 2014
Source Aarhus University Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: The Regional Committee on Biomedical Research Ethics
Study type Interventional

Clinical Trial Summary

Laser correction for myopia and astigmatism using an excimer laser has been performed with success for several years.

During the last 2 years, a new method for correction of refractive errors has emerged. In the method (ReLex) a femtosecond laser is used to cut a lenticule in the corneal stroma that is subsequently removed. For simple myopia this method has proved effective and on par with excimer baser LASIK. However, it remains to be determined if ReLEx is as effective in the treatment of astigmatism.

In the study, patients with high astigmatism are treated with conventional LASIK for astigmatism in one eye and with ReLEx for astigmatism in the other.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 50 Years
Eligibility Inclusion Criteria:

- Myopic astigmatism between -2.0 and -5.0 diopters

- Maximal difference in spherical equivalent refraction of 2 D between eyes

- No ocular or systemic disease

- Not pregnant or breastfeeding

- Minimum BSCVA of 0.8 (decimal)

- Normal corneal topography

- Sufficient corneal thickness to allow the treatment

Exclusion Criteria:

- Subjects not fulfilling the above criteria

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• ReLEx

• LASIK

Locations
Country Name City State
Denmark Department of Ophthalmology, Aarhus University Hospital Aarhus

Sponsors (1)
Lead Sponsor Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Visual acuity 1 year Yes
Secondary Refraction 1 year No
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04778501 - PMCF Study on Monofocal Toric IOL (PODEYE TORIC) in Asia N/A
Completed NCT04536571 - Vision Stability and Preference for Soft Toric vs. Soft Spherical Contact Lenses N/A
Completed NCT05039112 - Clinical Comparison of 2 Daily Disposable Toric Soft Contact Lenses N/A
Completed NCT04613882 - Quantification of the Visual Benefits of Soft Toric Contact Lenses Compared to Soft Spherical Contact Lenses N/A
Recruiting NCT05611294 - Contralateral Study of Topography Guided LASIK Versus Small Incision Lenticule Extraction N/A
Completed NCT05633082 - A Clinical Performance of Two Soft Toric Contact Lenses N/A
Not yet recruiting NCT05561296 - Astigmatism Management With Iris-registration Guided Corneal Relaxing Incisions or Toric IOLs During Cataract Surgery N/A
Not yet recruiting NCT05506553 - Comparison of Aspheric Toric Intraocular Lenses for Micro-monovision N/A
Completed NCT02847169 - Clinical Performance of Toric Hydrogel Contact Lenses Following One Week of Daily Wear N/A
Recruiting NCT02618018 - Clinical Evaluation of Efficacy and Stability of AT TORBI 709M 4-haptic Toric IOL in Cataract Surgery N/A
Completed NCT02555098 - A Bilateral Dispensing Clinical Trial of an Sapphire Lens Against Senofilcon A Toric for Astigmatism Lens N/A
Completed NCT02423109 - Bilateral Dispensing Study of Fanfilcon A Toric Versus Enfilcon A Toric Lenses N/A
Completed NCT02550353 - Changes Between Lenticule Extraction and Femtosecond Laser-assisted Laser in Situ Keratomileusis N/A
Completed NCT02551796 - Early Changes Among FLEx, LASIK and FS-LASIK N/A
Completed NCT02248766 - Clinical Performance of Habitual Wearers of Avaira Toric When Refitted With Clariti Toric Lenses N/A
Completed NCT01965288 - Clinical Performance of Biofinity Toric Versus Air Optix for Astigmatism N/A
Completed NCT01857102 - Toric Eye Strain and Stability Study N/A
Completed NCT02624791 - Evaluating and Improving Functional Driving Vision of Patients With Astigmatism N/A
Completed NCT01207466 - Evaluation of Two Daily Disposable Contact Lenses for Wearers With Astigmatism N/A
Completed NCT01211535 - Subjective Comfort With Multipurpose Care Solutions in Soft Contact Lens Wearers N/A