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Myoring Versus Keraring Implantation for Keratoconus

Sponsor
Shahid Beheshti University of Medical Sciences (Other)
Overall Status
Unknown status
CT.gov ID
NCT01869517
Collaborator
(none)
23
Enrollment
1
Location
2
Arms

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: intrastromal corneal ring segments (Keraring) implantation
  • Other: Intrastromal corneal continuous ring (Myoring) implantation
 Phase 2

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Primary Purpose:
Treatment
Study Start Date :
May 1, 2013
Anticipated Primary Completion Date :
May 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Intrastromal corneal continuous ring (Myoring)

Other: Intrastromal corneal continuous ring (Myoring) implantation
Active Comparator: Intrastromal corneal ring segments (Keraring)

Other: intrastromal corneal ring segments (Keraring) implantation

Outcome Measures

Primary Outcome Measures

  1. uncorrected visual acuity [6 months]

    Snellen E chart

Secondary Outcome Measures

  1. Corneal thickness [6months]

    Galilei Dual Scheimpflug Analyzer ( Ziemer, Switzerland)

  2. Corneal irregularities (3, 5 and 7 mm of central cornea) [6 months]

    Galilei Dual Scheimpflug Analyzer ( Ziemer, Switzerland)

  3. Front & back corneal elevation [6 months]

    Galilei Dual Scheimpflug Analyzer ( Ziemer, Switzerland)

  4. Corneal aberrometry [6 months]

    Galilei Dual Scheimpflug Analyzer ( Ziemer, Switzerland)

  5. Corneal eccentricity [6 months]

    Galilei Dual Scheimpflug Analyzer ( Ziemer, Switzerland)

  6. Corneal hysteresis & corneal resistance factor [6 months]

    Ocular response Analyzer (reichert ophthalmic instruments, Buffalo,New York ,USA)

  7. Intra and postoperative complications (glare, night vision problem, migration, extrusion, infection) [Intra and post operatien]

    clinical examination, patients history

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 40 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Islamic Republic OF Iran Tehran Iran, Islamic Republic of

Sponsors and Collaborators

  • Shahid Beheshti University of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zahra Rabbani Khah, clinical professor ,ophthalmic research center, Shahid Beheshti University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01869517
Other Study ID Numbers:
  • 91138
First Posted:
Jun 5, 2013
Last Update Posted:
Jun 5, 2013
Last Verified:
Jun 1, 2013
Additional relevant MeSH terms:
Keratoconus

Study Results

No Results Posted as of Jun 5, 2013