Myoring Versus Keraring Implantation for Keratoconus
1 other identifier
interventional
23
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 22, 2013
CompletedFirst Posted
Study publicly available on registry
June 5, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedJune 5, 2013
June 1, 2013
2 years
May 22, 2013
June 1, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
uncorrected visual acuity
Snellen E chart
6 months
Secondary Outcomes (7)
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
- +2 more secondary outcomes
Study Arms (2)
Intrastromal corneal continuous ring (Myoring)
ACTIVE COMPARATORIntrastromal corneal ring segments (Keraring)
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
- /200\<visual acuity \<20/30
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Islamic Republic OF Iran
Tehran, Iran
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- clinical professor ,ophthalmic research center
Study Record Dates
First Submitted
May 22, 2013
First Posted
June 5, 2013
Study Start
May 1, 2013
Primary Completion
May 1, 2015
Last Updated
June 5, 2013
Record last verified: 2013-06