A Clinical Study to evaluate the Outcome after implantation of two different commercially available Intra Stromal Rings combined with Collagen cross linking in patients with Keratoconus
Trial Snapshot
- Phase
- Not Applicable
- Status
- Other
- Sponsor
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- Uncorrected Visual acuity
Study Overview
Brief Summary
This is an Investigator Initiated prospective, comparative Clinical Study to evaluate and compare the Outcome of two different Intra Stromal Rings implantation along with corneal collagen cross-linking technique in patients with Keratoconus using a Femtosecond laser-assisted procedure. The objective of this study is to evaluate and compare the clinical outcomes of two different Intra Stromal Rings implanted in patients with Keratoconus a Femtosecond laser-assisted procedure in terms of Visual Acuity, Spherical Equivalent Diopter, Keratometry, corneal thickness, topographic pattern, Endothelial cell count & Corneal Astigmatism. The rationale of conducting this study is to demonstrate the clinical outcomes of ICRS in progressive Keratoconus at 3, 6 & 12 months following the procedure, using corneal topography. Since it is a newer, less invasive and less time consuming treatment modality it will help us treat the patients of Keratoconus more effectively who otherwise had little treatment options available. This study will follow ICH standards for clinical research including ICH –E6 (GCP) and ICH E3 (Study Reporting); ISO 14155 standards for Conduct of the study.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant, Investigator and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 35.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Unilateral/bilateral
- •A diagnosis of keratoconus, intolerance for contact lenses or glasses.
- •Progressing keratoconus.
- •(Decrease in visual acuity of at least 1 line excluding non-corneal causes of deterioration/ steepening of at least 1D in steepest keratometry over last 6 months/ more than 1 in prescription of change of glasses or contact lens over the last 2 years)
- •Patients with Keratometric readings ≥ 48 D
- •Patients ≥ 18 years of age
- •Patients with clear cornea
- •Patients with corneal thickness ≥ 450 microns at the proposed incision site.
- •Patient willing to participate and sign informed consent
- •Patient willing to come for all post-operative follow-up procedures as defined in study protocol.
Exclusion Criteria
- •Patients with maximum keratometry (K) values greater than 65.00 diopters (D),
- •Patients with keratometric readings < 48 D
- •Apical opacity and scarring.
- •Previous corneal or Intraocular surgery
- •Corneal thickness less than 450 microns at the planned site of Intrastromal rings implantation (5.0 mm optical zone).
- •Pregnancy & Lactation
- •Concurrent participation in another drug or device Study.
Outcomes
Primary Outcomes
Uncorrected Visual acuity
Time Frame: Pre-operative visit, 3, 6, and 12 Months Follow-up
Best Corrected Visual acuity
Time Frame: Pre-operative visit, 3, 6, and 12 Months Follow-up
Secondary Outcomes
- Refraction(Change in Topography patterns)