Evaluating Collagen Cross-Linking (CCL) Treatment in Norway

• Status: Unknown status
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess safety, efficacy and stability of riboflavin-UV induced cross-linking of corneal collagen in reducing the progression of keratecatasia and in improving visual acuity. This is the first Norwegian study concerning CCL.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ullevaal University Hospital
• Treatments: Dextrans; Ophthalmic Solutions; Riboflavin

Criteria

Inclusion Criteria:

1. Age from 20 to 45 years

2. Progressive keratectasia (primary or secondary) in an advanced stage

3. Decreased best corrected visual acuity bellow 20/40, which cannot be further improved by use of soft contact lenses

4. Rigid contact lenses are either not tolerated or do not improve visual acuity

5. No previous eye surgery (except for laser refractive surgery)

6. All patients must provide written informed consent to become a study subject

7. Subjects able to return for scheduled follow-up examinations according to this protocol

Exclusion Criteria:

1. Corneal thickness < 400 µm at thinnest position

2. Keratometric - readings above 60 diopters

3. Other active ocular disease than keratectasia

4. Herpes keratitis

5. Previous ocular surgery (other than laser refractive surgery)

6. Patients who were immunocompromised, pregnant or who had atopic syndrome, connective tissue or autoimmune disease

7. Patients with known sensitivity to study medication

8. Subjects with intraocular pressure > 23 mmHg by Goldmann applanation tonometry, a history of glaucoma, or glaucoma suspects

9. Subjects who intent to participate in other ophthalmic clinical trails during this clinical investigation