Keratoconus
Conditions
Interventions
The clinical study is an open-label, non-randomized 1-arm treatment. The study will evaluate a group of 30 participants, who have keratoconus with clinical indication to perform the Crosslinking-EpiON
biomicroscopy. On the 30th day after surgery, the participants will be submitted to exams of: uncorrected distance visual acuity, corrected distance visual acuity, refraction
anterior and posterior corneal surface elevation, corneal pachymetry, anterior chamber depth and volume, measurement of lens optical density values, corneal aberrometry, iridocorneal angle measurement
Sponsors
Hospital Universitário Gaffree e Guinle/HUGG/UNIRIO
Mediphacos Indústrias Médicas S.A.
Eligibility
Inclusion criteria
Inclusion criteria: Patients aged 12 years or older; patients diagnosed with keratoconus and a history of ectasia progression in the last 12 months or at risk of progression; minimum corneal thickness of 300 microns
Exclusion criteria
Exclusion criteria: Patients without indication for the treatment of Crosslinking; corneal thickness less than 300 microns; Vulnerable groups: pregnant women, breastfeeding women, children under 12 years of age, individuals whose capacity for self-determination is reduced or impeded, or in any way prevented from resisting, especially with regard to free and informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of the study is expected to assess the safety and efficacy of using a D3 scleral contact lens in the crosslinking procedure; for that, after the crosslinking, on the 7th postoperative day, the participants will be submitted to the exams of: uncorrected distance visual acuity, corrected distance visual acuity, refraction; biomicroscopy. On the 30th postoperative day, participants will be submitted to the following tests: uncorrected distance visual acuity, corrected distance visual acuity, refraction; biomicroscopy; anterior and posterior corneal surface elevation, corneal pachymetry, anterior chamber depth and volume, measurement of lens optical density values, corneal aberrometry, iridocorneal angle measurement; epithelial map and corneal thickness; measurement of ocular pressure, dynamic deformation for biomechanical study and corneal thickness | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess the level and time of riboflavin soaking of the cornea; this will be done using the Riboflavin rating scale that is already used in large-scale studies, with grade 3 being equivalent to the imbibition of 15 µg/g of riboflavin;Quality of life assessment and usability assessment of the D3 scleral contact lens will be performed comparing before and 30 days after the crosslinking surgery with the use of the D3 scleral contact lens, using the NEI VFQ-25 questionnaire. validated for portuguese language | — |
Countries
Brazil
Contacts
Public ContactRenato Ambrósio Júnior
Hospital Universitário Gaffree e Guinle/HUGG/UNIRIO
Outcome results
None listed