Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05055349
Other study ID # 324 : 11/2019
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 28, 2019
Est. completion date November 22, 2021

Study information

Verified date September 2021
Source Minia University
Contact ahmed maher khalafallah
Phone 01119094426
Email drahmedmaher1988@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To compare visual and refractive measurements of intrastromal corneal ring segments versus toric phakic posterior intra-ocular lenses implantation in keratoconus


Description:

- The study is a prospective comparative interventional case series. It will be conducted in Minia university hospital and Roaa Laser Vision Correction Center. - Fourty eyes will be evenly allocated into two groups: Group (A): 20 eyes will undergo corneal collagen cross linking (epithelium off) 1 month after Femtosecond laser assisted intrastromal corneal keraring segments. Group (B): 20 eyes will undergo toric phakic posterior IOL implantation 1 year after corneal collagen cross linking (epithelium off). • An informed written consent to be involved in the study will be obtained from each patient.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date November 22, 2021
Est. primary completion date November 15, 2021
Accepts healthy volunteers No
Gender All
Age group 21 Years to 40 Years
Eligibility Inclusion Criteria: - Keratoconus grade I to III according to the Amsler-Krumeich classification Exclusion Criteria: - Acute hydrops or grade IV keratoconus - Any ocular diseases or surgeries - Corneal thickness less than 400 µm at the thinnest corneal point, and at least 450 µm at the incision site for ICRS group - Corneal pacities

Study Design


Related Conditions & MeSH terms


Intervention

Other:
corneal ring segments
ring hard segments inserted within corneal stroma using femtolaser

Locations

Country Name City State
Egypt Ahmed Maher Khalafallah Minya

Sponsors (1)

Lead Sponsor Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary pentacam readings a device that read topometric corneal data and other data 1 month
See also
  Status Clinical Trial Phase
Recruiting NCT04570020 - Scleral Lens Fitting Using Wide-Field OCT
Recruiting NCT02921009 - McNeel Eye Center Corneal Crosslinking Study N/A
Terminated NCT02762253 - Study of the Safety and Effectiveness of Photochemically Induced Collagen Cross-Linking in Eyes With Keratoconus. Phase 2
Completed NCT01691651 - Botulinum Toxin A for the Treatment of Keratoconus N/A
Completed NCT01527708 - Accuracy of Curvature and Wavefront Aberrations of Posterior Corneal Surface, in Keratoconic and Post-CXL Corneas N/A
Completed NCT01527721 - Blurring Strength & Aberrometric Changes Following Corneal Cross-linking (CxL) and CxL Combined With Photorefractive Keratectomy (PRK) in Keratoconus N/A
Recruiting NCT00841386 - Treatment of Keratoconus Using Collagen Cross-Linking Phase 2/Phase 3
Completed NCT00347074 - A Clinical Study of Keratoconus in Asian Patients and Assessment of Different Topographic Patterns of Keratoconus in Asian Patients N/A
Completed NCT03187912 - Accelerated Corneal Cross-linking With Different Riboflavin Solutions Phase 3
Completed NCT00584285 - Corneal Topographer Fluorescein Patterns
Completed NCT03511495 - Reliability of Topography Measurements in Keratoconus
Not yet recruiting NCT05395650 - Cyanocobalamin as Photosensitizing Agent
Completed NCT04418999 - Safety and Efficacy of Intracanalicular Dexamethasone Compared to Loteprednol Etabonate in Patients With Keratoconus Early Phase 1
Completed NCT03235856 - Retrospective Digital Computer Analysis of Keratoconus Evolution - REDCAKE
Completed NCT05019768 - Topo-pachimetric Accelerated Epi-On Cross-linking Compared to Dresden Protocol Using Riboflavin With Vitamin E TPGS N/A
Withdrawn NCT01789333 - Higher Irradiance in Keratoconus Ectasia N/A
Completed NCT05114928 - Correlation Between Q-value Changes and Progression of Pediatric Keratoconus.
Completed NCT03647046 - Custom Anterior Surfacing of Scleral Lens for Vision Quality Improvement in Patients With Keratoconus N/A
Recruiting NCT04439552 - fMRI and IVCM Cornea Microscopy of CXL in Keratoconus
Recruiting NCT06100939 - Epithelium-On Corneal Cross-linking in Subjects 8 to 45 Years of Age With Keratoconus Phase 3