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Various approaches, including surgical and non-surgical management have been proposed for keratoconus. One of the surgical procedures is Intrastromal Corneal Ring implantations that have been designed to achieve refractive readjustment by flattening the cornea. There are different models of Intrastromal Corneal rings available: intrastromal corneal ring segments (ICRS) such as Keraring and intrastromal corneal continuous ring (ICCR) like Myoring.
Most studies of these two types of ring implantation outcomes are retrospective case series. Thus, this Randomized Clinical Trial study was designed with the aim of Comparing visual and refractive outcomes and complications of insertion Myoring versus Keraring using Femtosecond laser. Keratoconus patients with compound myopic astigmatism who meet the inclusion criteria will randomly allocated to the Keraring and Myoring groups. Subsequently, the clinical outcomes of two groups will be compared at one,3 and 6 months after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intrastromal corneal continuous ring (Myoring) | Active Comparator |
| |
| Intrastromal corneal ring segments (Keraring) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intrastromal corneal ring segments (Keraring) implantation | Other |
| ||
| Intrastromal corneal continuous ring (Myoring) implantation |
| Measure | Description | Time Frame |
|---|---|---|
| uncorrected visual acuity | Snellen E chart | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Corneal thickness | Galilei Dual Scheimpflug Analyzer ( Ziemer, Switzerland) | 6months |
| Corneal irregularities (3, 5 and 7 mm of central cornea) | Galilei Dual Scheimpflug Analyzer ( Ziemer, Switzerland) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alireza Baradaran-Rafii | Contact | 009822591616 | labbafi@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Islamic Republic OF Iran | Recruiting | Tehran | Iran |
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| ID | Term |
|---|---|
| D007640 | Keratoconus |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D004343 | Drug Implants |
| ID | Term |
|---|---|
| D003692 | Delayed-Action Preparations |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| Other |
|
| 6 months |
| Front & back corneal elevation | Galilei Dual Scheimpflug Analyzer ( Ziemer, Switzerland) | 6 months |
| Corneal aberrometry | Galilei Dual Scheimpflug Analyzer ( Ziemer, Switzerland) | 6 months |
| Corneal eccentricity | Galilei Dual Scheimpflug Analyzer ( Ziemer, Switzerland) | 6 months |
| Corneal hysteresis & corneal resistance factor | Ocular response Analyzer (reichert ophthalmic instruments, Buffalo,New York ,USA) | 6 months |
| Intra and postoperative complications (glare, night vision problem, migration, extrusion, infection) | clinical examination, patients history | Intra and post operatien |