Myoring Versus Keraring Implantation for Keratoconus

S

Shahid Beheshti University of Medical Sciences

Status and phase

Unknown
Phase 2

Conditions

Keratoconus

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT01869517
91138

Details and patient eligibility

About

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.

Sex

All

Ages

20 to 40 years old

Volunteers

No Healthy Volunteers

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

Trial design

23 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Alireza Baradaran-Rafii

Data sourced from clinicaltrials.gov

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