Myoring Versus Keraring Implantation for Keratoconus

Keratoconus Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01869517
• Other study ID #: 91138
• Status: Recruiting
• Phase: Phase 2
• First received: May 22, 2013
• Last updated: June 1, 2013
• Start date: May 2013

Study information

• Verified date: June 2013
• Source: hahid Beheshti University of Medical Sciences
• Contact: Alireza Baradaran-Rafii
• Phone: 009822591616
• Email: labbafi[@]hotmail.com
• Is FDA regulated: No
• Health authority: Iran :Ethic committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 23
• Est. primary completion date: May 2015
• Gender: Both
• Age group: 20 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Keratoconus

Intervention

Other:
• intrastromal corneal ring segments (Keraring) implantation

• Intrastromal corneal continuous ring (Myoring) implantation

Locations

Country	Name	City	State
Iran, Islamic Republic of	Islamic Republic OF Iran	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
hahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	uncorrected visual acuity	Snellen E chart	6 months
Secondary	Corneal thickness	Galilei Dual Scheimpflug Analyzer ( Ziemer, Switzerland)	6months
Secondary	Corneal irregularities (3, 5 and 7 mm of central cornea)	Galilei Dual Scheimpflug Analyzer ( Ziemer, Switzerland)	6 months
Secondary	Front & back corneal elevation	Galilei Dual Scheimpflug Analyzer ( Ziemer, Switzerland)	6 months
Secondary	Corneal aberrometry	Galilei Dual Scheimpflug Analyzer ( Ziemer, Switzerland)	6 months
Secondary	Corneal eccentricity	Galilei Dual Scheimpflug Analyzer ( Ziemer, Switzerland)	6 months
Secondary	Corneal hysteresis & corneal resistance factor	Ocular response Analyzer (reichert ophthalmic instruments, Buffalo,New York; ,USA)	6 months
Secondary	Intra and postoperative complications (glare, night vision problem, migration, extrusion, infection)	clinical examination, patients history	Intra and post operatien