An interventional study of LASIK in Hyperopia, sponsored by Minia University. Completed. Open to participants aged 18 Years to 61 Years. Per ClinicalTrials.gov, last updated 2017-07-21.
Sponsored by Minia University · Not applicable, Interventional, and Other
Analysis corneal and refractive stability of hyperopic laser-assisted in situ keratomileusis (LASIK) with and without concurrent prophylactic high-fluence cross-linking (CXL).
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.
140 studies on the registry are indexed under Hyperopia; 18 are open to participants now.
This study's enrollment of 25 is below the median of 60 across 112 interventional studies indexed under Hyperopia.
Browse Hyperopia studies →Minia University is the lead sponsor of 356 studies on the registry; 115 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
group 1:hyperopic customized LASIK with concurrent prophylactic high-fluence cross-linking
Procedure: LASIK
group 2: hyperopic customized LASIK only
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
assessment of changes in refractive spherical equivalent
assessment of changes in manifest refraction by autorefractometer and then calculate spherical equivalent
Time frame: preoperative and 3 months and 6 months postoperative
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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Minia University