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Combined Corneal Wavefront-guided TPRK and ACXL Following ICRS Implantation in Management of Moderate Keratoconus

NCT04383301 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2020-05-13

No results posted yet for this study

Summary

Background: Keratoconus leads to gradual progressive loss of vision in young and adult patients. For visual rehabilitation and to hinder keratoconus progressionthe investigators designed this study to help the keratoconus patients to improve and stabilize their vision.

Design: This is a prospective consecutive uncontrolled study.

Patients and Methods:

This study includes 36 eyes of 36 patients with moderate degree o keratoconus (KC) undergoing combined wave front guided transepithelial photorefractive keratectomy (TPRK) and accelerated corneal collagen crosslinking (ACXL) after intracorneal ring segment (ICRS) implantation. Uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), manifest refraction spherical equivalent (MRSE), corneal indices based on Scheimpflug tomography, higher-order aberrations (HOAs) will be evaluated at baseline, after ICRS implantation, and at1, 3, 6, and 12 months after combined TPRK and CXL.

Conditions

  • Keratoconus

Interventions

PROCEDURE

Intracorneal ring segment implantaion as the first stage

Intracorneal ring segment (ICRS)

PROCEDURE

ACXL and wafe front guieded TPRK as the second stage

Accelerated corneal cross linking (ACXL) and wafe front guided transepithelial photorefractive keratotomy (TPRK)

Sponsors & Collaborators

  • Shaaban Elwan

    lead OTHER

Principal Investigators

  • Ashraf M Bakhsh, MD · Security Forces Hospital Program

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
48 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2020-04-30
Completion
2020-04-30

Countries

  • Saudi Arabia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04383301 on ClinicalTrials.gov