Riboflavin-UVA Induced Collagen Crosslinking Treatment for Corneal Ectasia
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| ClinicalTrials.gov Identifier: NCT01123057 |
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Recruitment Status
: Unknown
Verified May 2010 by Singapore National Eye Centre.
Recruitment status was: Recruiting
First Posted
: May 14, 2010
Last Update Posted
: May 14, 2010
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Corneal Ectasia | Procedure: riboflavin-induced collagen cross-linking treatment Device: Riboflavin-UVA induced collagen cross-linking treatment for corneal ectasia | Not Applicable |
The purpose of this evaluation is to assess the safety and efficacy of riboflavin-UVA induced cross-linking treatment for corneal ectasia due to keratoconus and LASIK keratectasia. The principle of the procedure is to induce collagen crosslinking of the corneal stroma by the using riboflavin/UVA-treatment.
The technique involves topical application of riboflavin/dextran solution onto eye after removal of corneal epithelium. After initial riboflavin application for 30 minutes, UVA light is shone onto the cornea for another 30 minutes with continued topical riboflavin application.
A thorough examination is performed to evaluate the following pre-operatively:
- Manifest refraction results - Uncorrected visual acuity (UCVA) and best corrected visual acuity (BCVA)
- Cycloplegic refraction results - Uncorrected visual acuity (UCVA) and best corrected visual acuity (BCVA)
- Slit-lamp biomicroscopy and photography
- Intraocular pressure measurement
- Fundoscopy
- Corneal topography using Orbscan II and Pentacam
- Corneal aberrometry measurement using Technolas Zywave Aberrometer
- Endothelial cell count measurement using Konan noncontact endothelial cell analyser
- Confocal microscopy
- Corneal hysteresis measurement using Ocular Response Analyser
- Subjective feedback about quality of vision (VF 14 assessment) Post-operative Assessment (1 day, 1 week, 1 month, 3 months, 6 months and 1 year postoperatively)
- Uncorrected visual acuity and best corrected visual acuity with manifest refraction
- Cycloplegic refraction results - uncorrected visual acuity and best corrected visual acuity
- Subjective visual outcome rating
- Slit lamp examination and photography
- Fundoscopy
- Corneal topography
- Aberrometry measurement
- Endothelial cell count
- Confocal microscopy
- Corneal hysteresis measurement
- Report adverse events
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 30 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Riboflavin-UVA Induced Collagen Crosslinking Treatment for Corneal Ectasia |
| Study Start Date : | August 2008 |
| Estimated Primary Completion Date : | June 2010 |
| Estimated Study Completion Date : | June 2010 |
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Procedure: riboflavin-induced collagen cross-linking treatment
The principle of the procedure is to induce collagen crosslinking of the corneal stroma by the using riboflavin/UVA-treatment.
The technique involves topical application of riboflavin/dextran solution onto eye after removal of corneal epithelium. After initial riboflavin application for 30 minutes, UVA light is shone onto the cornea for another 30 minutes with continued topical riboflavin application.
- corneal topography [ Time Frame: 1 year ]The keratometry values will be monitored.
- visual acuity [ Time Frame: 1 year ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients must have clinical evidence of keratoconus or LASIK keratectasia (moderate to severe)
- Visual acuity with contact lenses must be better than or equal to 6/12 (20/40).
- Patients must be intolerant of contact lenses, i.e., they must be unable to wear contact lenses for a whole day.
- Patients should have a minimum of corneal thickness of 400um (with cornea at swollen state denuded of epithelium during surgery).
- In terms of general health, patients must not have any illnesses posing an immediate threat to life.
- Patients must over 18 years of age.
- Patients' contact lens wear must be stopped 3 days prior to preop assessment
- Patients can wear their lenses up to the day before the surgery
- Any vitamin C intake must be stopped 1 week prior to surgery
- Both eyes may be recruited if eligible.
- Patients with other non-inflammatory corneal thinning disorders such as pellucid marginal degeneration, keratoglobus and posterior keratoconus may be recruited
Exclusion Criteria:
- corneal thickness <400 µm in swollen state
- epithelial healing disorders (e.g. map-dot-fingerprint dystrophy, rheumatic disorders)
- refractive keratotomies
- corneal melting conditions
- herpes keratitis (UV can activate this herpes virus)
- associated systemic disorder such as Down's syndrome
- Pregnancy
- Breast-feeding.
- Patients with history of herpetic keratitis.
- Patients with autoimmune diseases
- Patients with IOP >21mmHg
- Patients with cataracts
- Patients taking part in other biomedical research in the 30 days prior to the start of this study.
- Patients with alcohol abuse, psychological weakness, or an uncooperative disposition.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01123057
| Singapore | |
| Singapore Eye Research Institute | Recruiting |
| Singapore, Singapore, 168751 | |
| Contact: Yeng Li Goh 6563224533 | |
| Principal Investigator: Li Lim, FRCS | |
| Principal Investigator: | Li Lim | Singapore National Eye Centre |
Publications:
| Responsible Party: | Lim Li, Singapore National Eye Centre |
| ClinicalTrials.gov Identifier: | NCT01123057 History of Changes |
| Other Study ID Numbers: |
R573/61/2007 |
| First Posted: | May 14, 2010 Key Record Dates |
| Last Update Posted: | May 14, 2010 |
| Last Verified: | May 2010 |
Keywords provided by Singapore National Eye Centre:
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keratoconus collagen cross-linking LASIK ectasia keratoconus,lasik ectasia |
Additional relevant MeSH terms:
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Dilatation, Pathologic Corneal Diseases Pathological Conditions, Anatomical Eye Diseases Riboflavin Vitamin B Complex |
Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Photosensitizing Agents Dermatologic Agents |