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Myoring Versus Keraring Implantation for Keratoconus

Primary Purpose

Keratoconus

Status
Unknown status
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
intrastromal corneal ring segments (Keraring) implantation
Intrastromal corneal continuous ring (Myoring) implantation
Sponsored by
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconus

Eligibility Criteria

20 Years - 40 Years (Adult)All Sexes

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

Sites / Locations

  • Islamic Republic OF IranRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Intrastromal corneal continuous ring (Myoring)

Intrastromal corneal ring segments (Keraring)

Arm Description

Outcomes

Primary Outcome Measures

uncorrected visual acuity
Snellen E chart

Secondary Outcome Measures

Corneal thickness
Galilei Dual Scheimpflug Analyzer ( Ziemer, Switzerland)
Corneal irregularities (3, 5 and 7 mm of central cornea)
Galilei Dual Scheimpflug Analyzer ( Ziemer, Switzerland)
Front & back corneal elevation
Galilei Dual Scheimpflug Analyzer ( Ziemer, Switzerland)
Corneal aberrometry
Galilei Dual Scheimpflug Analyzer ( Ziemer, Switzerland)
Corneal eccentricity
Galilei Dual Scheimpflug Analyzer ( Ziemer, Switzerland)
Corneal hysteresis & corneal resistance factor
Ocular response Analyzer (reichert ophthalmic instruments, Buffalo,New York ,USA)
Intra and postoperative complications (glare, night vision problem, migration, extrusion, infection)
clinical examination, patients history

Full Information

First Posted
May 22, 2013
Last Updated
June 1, 2013
Sponsor
Shahid Beheshti University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01869517
Brief Title
Myoring Versus Keraring Implantation for Keratoconus
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
May 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Allocation
Randomized
Enrollment
23 (false)

8. Arms, Groups, and Interventions

Arm Title
Intrastromal corneal continuous ring (Myoring)
Arm Type
Active Comparator
Arm Title
Intrastromal corneal ring segments (Keraring)
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
intrastromal corneal ring segments (Keraring) implantation
Intervention Type
Other
Intervention Name(s)
Intrastromal corneal continuous ring (Myoring) implantation
Primary Outcome Measure Information:
Title
uncorrected visual acuity
Description
Snellen E chart
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Corneal thickness
Description
Galilei Dual Scheimpflug Analyzer ( Ziemer, Switzerland)
Time Frame
6months
Title
Corneal irregularities (3, 5 and 7 mm of central cornea)
Description
Galilei Dual Scheimpflug Analyzer ( Ziemer, Switzerland)
Time Frame
6 months
Title
Front & back corneal elevation
Description
Galilei Dual Scheimpflug Analyzer ( Ziemer, Switzerland)
Time Frame
6 months
Title
Corneal aberrometry
Description
Galilei Dual Scheimpflug Analyzer ( Ziemer, Switzerland)
Time Frame
6 months
Title
Corneal eccentricity
Description
Galilei Dual Scheimpflug Analyzer ( Ziemer, Switzerland)
Time Frame
6 months
Title
Corneal hysteresis & corneal resistance factor
Description
Ocular response Analyzer (reichert ophthalmic instruments, Buffalo,New York ,USA)
Time Frame
6 months
Title
Intra and postoperative complications (glare, night vision problem, migration, extrusion, infection)
Description
clinical examination, patients history
Time Frame
Intra and post operatien

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alireza Baradaran-Rafii
Phone
009822591616
Email
labbafi@hotmail.com
Facility Information:
Facility Name
Islamic Republic OF Iran
City
Tehran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alireza Baradaran-Rafii
Phone
009822591616
Email
labbafi@hotmail.com

12. IPD Sharing Statement

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Myoring Versus Keraring Implantation for Keratoconus

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