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OpenTrials
Completed

NCT Number: NCT02943967

Corneal Cross-linking and Refractive Surface Ablation in Patients With Asymmetric Corneas

The purpose of this study is to evaluate safety and efficacy of corneal cross-linking and photorefractive keratectomy for refractive correction in patients with bilateral asymmetric topography.

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Key information

Age range

23 year–51 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of São Paulo

São Paulo, 04023-062, Brazil

About this study

Corneal cross-linking (CXL) by the photosensitizer, riboflavin (vitamin B2), and ultraviolet A (UVA) light increases corneal rigidity and has been described as an effective method for stabilizing the cornea in patients with progressive keratoconus. The photochemical reaction in this procedure causes the collagen to form additional covalent connections between its fibers, which stabilizes the stromal collagen fibers, improving the collagen's structure and the cornea rigidity. It is a relatively safe procedure with low rates of complications Photorefractive keratectomy (PRK) it is a traditional technique for refractive surgery. In cases of irregular corneas or re-operation normally the favorite ablation profile chosen is the guided surgery, topography guided or wavefront guided, showing better results. This technique is also relatively safe procedure with low rates of complications. One of the most unwanted complications of this surgery and also rare is corneal ectasia.

Combining PRK and CXL is already done in patients with keratoconus and suspected keratoconus.

This combined procedure uses the principle that CXL stiffen the cornea making it possible to reduce corneal thickness with PRK without weakening corneal strength. Literature show better results, in keratoconus, with simultaneous procedures. Guedj et al performed PRK in keratoconus suspects and within 5 years he did not found any corneal ectasia.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • bilateral asymmetric topography with inferior steepening
  • corneal thickness of 440 micra at the thinnest point
  • inferior-to-superior index (I-S) between 1.0D and 1.4D
  • maximum keratometric steepness < 47.00D
  • stable refraction more than 1 year.

Exclusion criteria

  • forme fruste keratoconus and keratoconus
  • previous eye surgery
  • previous eye trauma
  • confirmed pregnancy

Treatment and study plan

CXL + PRK group

Procedure

Corneal cross-linking with subsequent photorefractive keratotomy after 6 months was performed in one eye

PRK group

Procedure

Photorefractive keratotomy alone was performed in contra lateral eyes

Primary outcomes

  1. Refractive results - spherical equivalent in diopters

    Time frame: 30 months

Secondary outcomes

  1. Biomicroscopy findings with the slit lamp

    Time frame: 30 months

  2. Visual acuity in logMar

    Time frame: 30 months

  3. Aberrometric Results in root mean square

    Time frame: 18 months

    Only coma and spherical aberration

  4. Topographic results in diopters

    Time frame: 30 months

    we will measure the increase in diopters with time

  5. Pachymetric results in micra

    Time frame: 30 months

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

Two Years Follow up of Corneal Cor Cross-linking and Refractive Surface Ablation in Patients With Asymmetric Corneal Topography

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Oct 25, 2016
Registry last updated
Oct 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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