Visual and Optics Impact of Refractive Surgery

NCT02889588 | Completed

• 1 other identifier: DGL_2015_20
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Refractive Disorders

Keywords

Refractive Surgery; higher order aberrations

Outcome Measures

Primary Outcomes (1)

• number of high order aberrations after refractive surgery

  3 months after baseline

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients undergoing refractive surgery

You may qualify if:

• patient candidate for Laser in Situ Keratomileusis (LASIK) refractive surgery
• to 40 years old
• corrective glasses or lenses ranging from -9.00 to + 6.00 diopter
• astigmatism less than or equal to 5 diopter

You may not qualify if:

• patient opposition to participate in the study
• patient under legal protection
• Pregnant or breast feeding patient
• no health insurance coverage

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Fondation Ophtalmologique Adolphe de Rothschild

Paris, 75019, France

Location

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Imène SALAH

  Fondation OPH A de Rothschild

  STUDY DIRECTOR

• Damien GATINEL, MD

  Fondation OPH A de Rothschild

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2016
• First Posted: September 5, 2016
• Study Start: June 1, 2015
• Primary Completion: August 31, 2017
• Study Completion: March 15, 2018
• Last Updated: March 27, 2018

Record last verified: 2018-03

Locations

FR (1)