Comparison Between TICL and ICL+AK for High Myopic Astigmatism

Astigmatism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03202485
• Other study ID #: TICL compare with ICL+AK
• Status: Completed
• Phase: N/A
• First received: June 22, 2017
• Last updated: June 27, 2017
• Start date: March 3, 2014
• Est. completion date: January 1, 2017

Study information

• Verified date: June 2017
• Source: Wenzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: January 1, 2017
• Est. primary completion date: March 2, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Astigmatism
• High Myopia
• Myopia

Intervention

Device:
• Toric Implantable Collamer Lens
uses Toric Implantable Collamer Lens implantation to correct the high myopic astigmatism.
• ICL + Astigmatic keratotomy
uses Implantable Collamer Lens implantation combined with Astigmatic keratotomy to correct the high myopic astigmatism

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wenzhou Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uncorrected Visual Acuity (UCVA) at distance	measured at 5 meter	2 years after surgery
Primary	astigmatism	astigmatism getting from subjective refraction	2 years after surgery
Secondary	Best Corrected Visual Acuity (BCVA) at distance	subjective refraction	2 years after surgery
Secondary	Spherical Equivalent (SE)	subjective refraction	2 years after surgery
Secondary	mean postoperative BCVA/mean preoperative BCVA	safety index	2 years after surgery
Secondary	mean postoperative UCVA/mean preoperative BCVA	efficacy index	2 years after surgery