Effectiveness of customized corneal crosslinking versus standard corneal crosslinking in patients with progressive keratoconus

Completed

Conditions: abnormal cone-shaped protrusion of the cornea
conical cornea
10002693

Registration Number: NL-OMON52376

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 124

Inclusion Criteria

- age 16 to 45 years old
- progressive keratoconus based on 1 or more of the following changes within 12
months: (1) an increase in keratometry (Kmax, K1, K2) of 1 diopter (D) or (2)
10% decrease of corneal thickness or (3) 1 D increase in myopia or refractive
astigmatism

Exclusion Criteria

- Corneal scarring
- Corneal disease other than keratoconus
- History of corneal surgery (e.g. refractive surgery, corneal transplantation,
intracorneal ring segments)
- Corneal thickness including epithelium less than 400 µm
- Pregnancy
- Among patients in whom both eyes are eligible only the first eye which is
undergoing corneal cross-linking is enrolled in the study
- Patient unwilling or unable to give informed consent, unwilling to accept
randomization or inability to complete follow-up (e.g. hospital visits) or
comply with study procedures
- Participation in another clinical study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The change in maximum keratometry (Kmax) 12 months after CXL.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. To evaluate non-inferiority regarding other relevant parameters of<br /><br>effectiveness<br /><br>a. Uncorrected Distance Visual Acuity (UDVA) and Corrected Distance<br /><br>Visual Acuity (CDVA)<br /><br>b. Spherical Equivalent (S.E.)<br /><br>c. Thinnest corneal point (pachymetry)<br /><br>d. Demarcation line<br /><br>e. Zonal Kmax<br /><br>f. Steep keratometry (K1) and flat keratometry (K2)<br /><br>g. Dutch Crosslinking for Keratoconus (DUCK) score<br /><br>h. ABCD-score<br /><br>2. To evaluate success/failure rate of cCXL versus sCXL based on progression<br /><br>after treatment<br /><br>3. To evaluate the safety of cCXL regarding endothelial cell count<br /><br>4. To evaluate the rate of reepithelisation after cCXL<br /><br>5. To evaluate patient satisfaction for cCXL compared to sCXL, using patients<br /><br>reported outcome measures (PROMs)<br /><br>6. To evaluate difference in ocular pain after cCXL and sCXL </p><br>