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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pocket ICRS | Active Comparator | Patients in this group underwent 360-degree MyoRing implantation through a femtosecond laser-assisted corneal pocket creation for the management of their central keratoconus. |
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| Tunnel ICRS | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intrastromal corneal ring segment implantation (Pocket) | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Complications | Postoperative complications following intrastromal corneal ring segment implantation. | 12 months |
| Postoperative keratometry | Postoperative keratometry as measured by Scheimpflug imaging Pentacam | 12 months |
| Postoperative Refraction | Spherical equivalent refraction measured by Topcon Auto-Keratorefractometer | 12 months |
| Corrected distance visual acuity (CDVA) | Corrected distance visual acuity measurement using Snellen's Acuity Chart expressed as logMAR notation | 12 months |
| Uncorrected distance visual acuity (UDVA) | Uncorrected distance visual acuity measurement using Snellen's Acuity Chart expressed as logMAR notation | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mahmoud Abdel-Radi, MD | Assiut University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tiba Eye Center | Asyut | Asyut Governorate | 71516 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33579160 | Result | Izquierdo L Jr, Rodriguez AM, Sarquis RA, Altamirano D, Henriquez MA. Intracorneal circular ring implant with femtosecond laser: Pocket versus tunnel. Eur J Ophthalmol. 2022 Jan;32(1):176-182. doi: 10.1177/1120672121994729. Epub 2021 Feb 12. | |
| 41263332 | Derived | Abdel-Radi M, Anwar M, Mostafa MM. Complications and Outcomes of Femtosecond Laser-Assisted Corneal Pocket Implantation of 360-Degree MyoRing(R) Versus Corneal Tunnel Implantation of 340-Degree Keraring(R) for the Management of Central Keratoconus. Curr Eye Res. 2026 Mar;51(3):231-239. doi: 10.1080/02713683.2025.2587890. Epub 2025 Nov 20. |
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| ID | Term |
|---|---|
| D007640 | Keratoconus |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
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| Intrastromal corneal ring segment implantation (Tunnel) | Procedure | 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. |
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