EUCTR2012-004410-34-ES
Active, not recruiting
Not Applicable
Influence of timolol maleate (ophthalmic gel 1 mg/g) on the keratometry and the parameters of corneal biomechanics in patients with keratoconus.
Cristina Peris Martínez0 sitesStarted: October 29, 2012Last updated:
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Cristina Peris Martínez
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1\.Male or female, from 18 years of age.
- •2\.Patients with keratoconus grade I, II, or III on the Amsler\-Krumeick scale
- •3\.Patient must provide written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 20
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 10
Exclusion Criteria
- •1\.Patient with keratoconus grade IV on the Amsler\-Krumeick
- •2\.Any other ectasia including secundary ioatrogenic ectasia after Lasik surgery, radial keratotomy, traumatic ectasia, etc.
- •3\.Lid anatomic or functional anomaly affecting blinking function
- •4\. Any ocular or systemic pathology affecting the normal ocular function and interfering with study results.
- •5\. Contact lenses wear at the inclusion visit and for whole study time.
- •6\. Any corneal surgery.
- •7\. Any ocular surgery including refractive surgery, intraocular surgery or lid surgery, modifying the corneal surface of the patients.
- •8\. History of any ocular trauma, ocular inflammation or ocular infection (viral, bacterial, fungal, protozoal).
- •9\. Within the 30 days before the Screening Visit history of any ocular pathology requesting topical treatment.
- •10\. Patients with glaucoma or ocular hypertension
Investigators
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