Visual and Optics Impact of Refractive Surgery

Refractive Disorders Clinical Trial

— CRIVO  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02889588
• Other study ID #: DGL_2015_20
• Status: Completed
• First received: August 31, 2016
• Last updated: March 26, 2018
• Start date: June 2015
• Est. completion date: March 15, 2018

Study information

• Verified date: March 2018
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Refractive surgery includes interventions to correct refractive errors, using a medical device such as a laser or an implant (intraocular lenses) or surgical instruments. The study distinguishes corneal interventions, carried on the surface of the eye, and intraocular interventions, performed on the lens or in the anterior or posterior chamber of the eye. The number of procedures in refractive surgery is growing significantly. They seem to offer satisfactory visual results but a number of issues remains unresolved. In order to get emmetropia, refractive surgery corrects optical defects by decreasing aberrations of lower orders (ie spherical refractive error and astigmatism). This increases high-order aberrations (the most common is a bright halo on the edge of the image). The cutting of the flap to the surface of the cornea in the case of LASIK increases high-order aberrations, which have the effect of reducing post-surgical visual performance (ie visual acuity and contrast sensitivity) and can't be corrected by glasses, while the adaptation of contact lenses on a post-operative cornea is more complex. It is therefore necessary to limit these post-surgical aberrations and to identify their possible sources. Indeed, some authors have provided insight into the effects of some high-order aberrations, but the influence of several factors characterizing the preoperative eye on refractive surgery are still unknown, such as pupillary diameter, depth of the anterior chamber, Intra Ocular Pressure or astigmatism.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 15, 2018
• Est. primary completion date: August 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• patient candidate for Laser in Situ Keratomileusis (LASIK) refractive surgery

• 18 to 40 years old

• corrective glasses or lenses ranging from -9.00 to + 6.00 diopter

• astigmatism less than or equal to 5 diopter

Exclusion Criteria:

• patient opposition to participate in the study

• patient under legal protection

• Pregnant or breast feeding patient

• no health insurance coverage

Related Conditions & MeSH terms

• Refractive Disorders
• Refractive Errors

Locations

Country	Name	City	State
France	Fondation Ophtalmologique Adolphe de Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of high order aberrations after refractive surgery		3 months after baseline