Hyperopic LASIK With Crosslinking Versus Standard LASIK

Hyperopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03224013
• Other study ID #: Hyperopic LASIK
• Status: Completed
• Phase: N/A
• First received: July 15, 2017
• Last updated: July 18, 2017
• Start date: January 18, 2016
• Est. completion date: July 12, 2017

Study information

• Verified date: July 2017
• Source: Minia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: July 12, 2017
• Est. primary completion date: May 12, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 61 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperopia

Intervention

Procedure:
• LASIK
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Minia University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assessment of changes in refractive spherical equivalent	assessment of changes in manifest refraction by autorefractometer and then calculate spherical equivalent	preoperative and 3 months and 6 months postoperative