An interventional study of Corneal Collagen Crosslinking and Ufalink in Keratoconus, sponsored by Ufa Eye Research Institute. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-10-29.
Sponsored by Ufa Eye Research Institute · Not applicable, Interventional, and Treatment
A complete intrastromal ring, MyoRing (Dioptex, GmbH, Linz, Austria), suggested by Albert Daxer in 2007, is a relatively new technique that has been demonstrated to treat keratoconus safely and effectively.Corneal collagen crosslinking (CXL), introduced by Wollensak et al. in 2003, has become a standard treatment for progressive keratoconus to slow or possibly stop progression of disease.
The formation of the stromal pocket during MyoRing implantation offers the opportunity for simultaneous introduction of riboflavin 0.1% into the pocket followed by UVA irradiation to provide combined treatment in patients with progressive keratoconus.
307 studies on the registry are indexed under Keratoconus; 56 are open to participants now.
This study's enrollment of 16 is below the median of 40 across 203 interventional studies indexed under Keratoconus.
Browse Keratoconus studies →Ufa Eye Research Institute is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Surgical technique: Implantation of a MyoRing in a corneal pocket was performed by using a PocketMaker microkeratome a guided, vibrating diamond blade to create a stromal pocket 9 mm in diameter at a 300-μm depth via a 4- to 5-mm-wide corneal tunnel followed by Corneal Collagen Crosslinking (standard surface UVA irradiation (370 nm, 3 mW/cm2) using Ufalink device)
Procedure: Corneal Collagen Crosslinking · Device: Ufalink
Sterile riboflavin solution 0.1% was then continuously injected for 3 minutes into the corneal pocket via a standard 0.3-mm cannula through the incision tunnel. Standard surface UVA irradiation (370 nm, 3 mW/cm2) was then applied at a 5-cm distance for 30 minutes. After UVA irradiation, a flexible MyoRing intracorneal implant was inserted into the corneal pocket,
UVA irradiation with wave length 370 nm, 3 mW/cm2 is provided with UFalink, device,Russian Federation
K max
Using topography measurements, decrease of maximum keratometry value over the preoperative maximum keratometry value
Time frame: 2 years
Visual acuity as assessed by Decimal system
Decimal visual acuity assessed on a study later was converted to the logarithm of minimal angle of resolution (logMAR).
Time frame: 2 years
No study locations are listed for this record.
This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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Ufa Eye Research Institute