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CompletedNCT02889588CRIVOUpdated Mar 27, 2018

Visual and Optics Impact of Refractive Surgery

An observational study in Refractive Disorders, sponsored by Fondation Ophtalmologique Adolphe de Rothschild. Completed at 1 site in France. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2018-03-27.

Sponsored by Fondation Ophtalmologique Adolphe de Rothschild · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
60
Ages
18 Years to 40 Years
Sex
All
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Study 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.

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Conditions studied

  • Refractive Disorders

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Keywords

  • Refractive Surgery
  • higher order aberrations
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In context

Refractive Errors

413 studies on the registry are indexed under Refractive Errors; 62 are open to participants now.

This study's enrollment of 60 is below the median of 150 across 107 observational studies indexed under Refractive Errors.

Browse Refractive Errors studies →

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild is the lead sponsor of 311 studies on the registry; 77 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients undergoing refractive surgery

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

Exclusion Criteria:

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

Observational model
Other
Time perspective
Prospective
Enrollment
60 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. number of high order aberrations after refractive surgery

    Time frame: 3 months after baseline

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Study locations

1 site
  • Fondation Ophtalmologique Adolphe de Rothschild
    Paris, 75019, France
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02889588
Lead sponsor
Fondation Ophtalmologique Adolphe de Rothschild
Responsible party
Sponsor
First posted
Sep 5, 2016
Start date
Jun 2015
Primary completion
Aug 31, 2017
Completion
Mar 15, 2018
Last update
Mar 27, 2018

Study contacts

Imène SALAH
study director · Fondation OPH A de Rothschild
Damien GATINEL, MD
principal investigator · Fondation OPH A de Rothschild
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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