Myoring Versus Keraring Implantation for Keratoconus
Trial Snapshot
- Phase
- Phase 2
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- uncorrected visual acuity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 20 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Arms & Interventions
Intrastromal corneal ring segments (Keraring)
Intervention: intrastromal corneal ring segments (Keraring) implantation (Other)
Intrastromal corneal continuous ring (Myoring)
Intervention: Intrastromal corneal continuous ring (Myoring) implantation (Other)
Outcomes
Primary Outcomes
uncorrected visual acuity
Time Frame: 6 months
Snellen E chart
Secondary Outcomes
- Corneal thickness(6months)
- Corneal irregularities (3, 5 and 7 mm of central cornea)(6 months)
- Front & back corneal elevation(6 months)
- Corneal aberrometry(6 months)
- Corneal eccentricity(6 months)
- Corneal hysteresis & corneal resistance factor(6 months)
- Intra and postoperative complications (glare, night vision problem, migration, extrusion, infection)(Intra and post operatien)
Investigators
Zahra Rabbani Khah
clinical professor ,ophthalmic research center
Shahid Beheshti University of Medical Sciences