An interventional study of Intrastromal corneal ring segment implantation (Pocket) and Intrastromal corneal ring segment implantation (Tunnel) in Keratoconus, sponsored by Assiut University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-31.
Sponsored by Assiut University · Not applicable, Interventional, and Treatment
Keratoconus is a corneal degenerative disease associated with loss of best-corrected visual acuity. The use of intrastromal corneal ring segment implants is indicated to regularize the cornea and to reduce aberrations.
Keratoconus is a corneal degenerative disease characterized by corneal thinning and subsequent development of irregular astigmatism, diminution of vision and loss of best-corrected visual acuity.
Management of keratoconus includes halting disease progression through a corneal strengthening procedure called corneal collagen cross-linking (CXL) which usually results in stabilizing the condition but with no improvement in visual acuity or quality. Intrastromal corneal ring segment (ICRS) implantation is a well-established procedure for the management of moderate keratoconus with a corneal flattening effect that is associated with improvement of visual acuity and reduction of optical aberrations.
The aim of the study is to evaluate and compare the visual, refractive and topographic outcomes of two different femtosecond laser assisted surgical techniques to create a corneal stromal pocket or a tunnel for implantation of ICRS for the management of central keratoconus
312 studies on the registry are indexed under Keratoconus; 56 are open to participants now.
This study's enrollment of 74 is above the median of 40 across 205 interventional studies indexed under Keratoconus.
Browse Keratoconus studies →Assiut University is the lead sponsor of 5,050 studies on the registry; 2,174 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Patients in this group underwent 360-degree MyoRing implantation through a femtosecond laser-assisted corneal pocket creation for the management of their central keratoconus.
Procedure: Intrastromal corneal ring segment implantation (Pocket)
Patients in this group are underwent 340-degree KeraRing implantation through a femtosecond laser-assisted corneal tunnel creation for the management of their central keratoconus.
Procedure: Intrastromal corneal ring segment implantation (Tunnel)
Patients in this group are planned to undergo ICRS implantation through a femtosecond laser-assisted pocket creation. The device creates an intrastromal corneal pocket of 8-mm diameter and a depth of nearly 80% of the corneal thickness at the thinnest location with a superior tunnel incision at 90° of 5-mm width.
Patients in this group are planned to undergo ICRS implantation through a femtosecond laser-assisted tunnel creation. The device creates an intrastromal tunnel with a depth of nearly 80% of the corneal thickness at the site of implantation. The tunnel inner and outer diameters are at 5 and 6 mm from the corneal center, respectively with the incision located at the steepest keratometry axis.
Complications
Postoperative complications following intrastromal corneal ring segment implantation.
Time frame: 12 months
Postoperative keratometry
Postoperative keratometry as measured by Scheimpflug imaging Pentacam
Time frame: 12 months
Postoperative Refraction
Spherical equivalent refraction measured by Topcon Auto-Keratorefractometer
Time frame: 12 months
Corrected distance visual acuity (CDVA)
Corrected distance visual acuity measurement using Snellen's Acuity Chart expressed as logMAR notation
Time frame: 12 months
Uncorrected distance visual acuity (UDVA)
Uncorrected distance visual acuity measurement using Snellen's Acuity Chart expressed as logMAR notation
Time frame: 12 months
Plan to share: No
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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