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Completed

NCT Number: NCT03224013

Hyperopic LASIK With Crosslinking Versus Standard LASIK

Analysis corneal and refractive stability of hyperopic laser-assisted in situ keratomileusis (LASIK) with and without concurrent prophylactic high-fluence cross-linking (CXL).

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Key information

Conditions

Hyperopia Eye Diseases Refractive Errors

Age range

18 year–61 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Interventional prospective consecutive comparative case control series of cases; 50 eyes of 25 patients with mean age 35.7 ± 12.4 (Range 18-61years) with hyperopia or hyperopic astigmatism underwent customized LASIK with concurrent prophylactic high-fluence cross-linking in right eye (group 1) and customized LASIK only in left eye (group 2). Cases with hyperopia +1 diopter to +6 diopters or hyperopic astigmatism up to 4 diopters were included in the study. Patients with previous intraocular or corneal surgery, active corneal disease were excluded from the study.

Main outcome measures were uncorrected visual acuity (UCVA), manifest refractive spherical equivalent (MRSE), cycloplegic refractive spherical equivalent (CRSE), keratometric measurements and spherical aberrations at 4 mm and maximum pupil and their evolution along 6 months postoperatively.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Cases with hyperopia +1diopter to +6 diopters or hyperopic astigmatism up to 4 diopters

Exclusion criteria

  • Patients with previous intraocular or corneal surgery, active corneal disease

Treatment and study plan

LASIK

Procedure

LASIK with concurrent prophylactic high fluence crosslinking in right eye ( After the excimer laser ablation, and with the flap folded onto itself and protected with a dry sponge, one drop of Vibex Rapid™ , consisting of 0.10% saline-diluted riboflavin (a very slightly hypotonic solution, mixed with hydroxypropyl methylcellulose, a dextran substitute), was placed on the exposed stromal bed afforded by the open LASIK flap and carefully spread over the bed area with an irrigating cannula for 60 seconds and LASIK only in left eye

Primary outcomes

  1. assessment of changes in refractive spherical equivalent

    Time frame: preoperative and 3 months and 6 months postoperative

    assessment of changes in manifest refraction by autorefractometer and then calculate spherical equivalent

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

Hyperopic LASIK With Concurrent Prophylactic High-fluence Cross-linking Versus Standard LASIK Outcomes

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 21, 2017
Registry last updated
Jul 21, 2017

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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