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Hyperopic LASIK With Crosslinking Versus Standard LASIK

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03224013
Enrollment
25
Registered
2017-07-21
Start date
2016-01-18
Completion date
2017-07-12
Last updated
2017-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperopia

Brief summary

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

Detailed 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.

Interventions

PROCEDURELASIK

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

Sponsors

Minia University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model 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 +1D to +6D or hyperopic astigmatism up to 4D 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 measurments and spherical aberrations at 4 mm and maximum pupilnand their ecolution along 6 months postoperatively.

Eligibility

Sex/Gender
ALL
Age
18 Years to 61 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
assessment of changes in refractive spherical equivalentpreoperative and 3 months and 6 months postoperativeassessment of changes in manifest refraction by autorefractometer and then calculate spherical equivalent

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026