Myoring Versus Keraring Implantation for Keratoconus

NCT ID: NCT01869517

Last Updated: 2013-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Keratoconus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Study Groups

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Intrastromal corneal continuous ring (Myoring)

Group Type ACTIVE_COMPARATOR

Intrastromal corneal continuous ring (Myoring) implantation

Intervention Type OTHER

Intrastromal corneal ring segments (Keraring)

Group Type ACTIVE_COMPARATOR

intrastromal corneal ring segments (Keraring) implantation

Intervention Type OTHER

Interventions

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intrastromal corneal ring segments (Keraring) implantation

Intervention Type OTHER

Intrastromal corneal continuous ring (Myoring) implantation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* keratoconus patients and :
* age between 20 to 40
* corneal thickness\> 380 microns
* mean keratometry between 44 to 60 D
* clear central cornea
* Patients should be discontinued their contact lenses for 3 weeks prior to the exams
* contact lenses in tolerance
* 20/200\<visual acuity \<20/30

Exclusion Criteria

* Positive pregnancy test
* Breast-feeding
* History of glaucoma, cataract, vernal and atopic keratoconjunctivitis
* History of previous ophthalmologic surgery, keratorefractive surgery on the operative eye
* Dry eye
* Corneal stromal disorders
* History of herpetic keratitis
* Pellucid marginal degeneration
* Corneal grafts
* Retinal disorders
* Nystagmus and uncooperative disposition
* Neuro-ophthalmologic disorders
* Intraocular pressure \<10 mmHg or \>21 mmHg
* Patients with autoimmune, connective tissue disorders, diabetes and immunosuppressive drugs users
* Hyperopia
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Zahra Rabbani Khah

clinical professor ,ophthalmic research center

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Islamic Republic OF Iran

Tehran, , Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Alireza Baradaran-Rafii

Role: CONTACT

009822591616

Facility Contacts

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Alireza Baradaran-Rafii

Role: primary

009822591616

Other Identifiers

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91138

Identifier Type: -

Identifier Source: org_study_id

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