PED-CXL: Conventional Collagen Crosslinking in Young Keratoconus
Study Details
Study Description
Brief Summary
Keratoconus is a chronic progressive non - inflammatory disorder characterised by progressive steepening and thinning of cornea and high myopic astigmatism, accounting for poor visual acuity in such individuals. Keratoconus seems to be more advanced on presentation, in young patients.
The investigators intend to evaluate the effectiveness of conventional collagen cross linking in young patients diagnosed with keratoconus.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Keratoconus is progressive ectatic corneal disorder characterised by progressive corneal thinning, steep corneal curvatures and usually associated with high irregular myopic astigmatism.
The major problems concerning keratoconus in young patients are;
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Rapid rates of progression in young keratoconic corneas as compared to adults.
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Poor biomechanical properties of young corneas.
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Poor quality of vision, which predisposes to a very poor quality of life.
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High rates of complications and failure post keratoplasty in young patients.
The investigators intend to evaluate the effectiveness of conventional collagen crosslinking in young patients with keratoconus with regards to keratometric indices and visual acuity.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Conventional CXL Crosslinking was done according to the standard protocol using hypo-osmolar riboflavin to saturate the cornea following epithelial debridement and ultra - violet light of 370nm with energy density of 3 milliwatts/sq.cm with riboflavin and distilled water alternated every 2 minutes was used for the procedure. |
Radiation: Conventional CXL
Crosslinking was done according to the standard protocol using hypo-osmolar riboflavin (<0.1%) to saturate the cornea following epithelial debridement and ultra - violet light of 370nm with energy density of 3 milliwatts/cm2 with riboflavin and distilled water alternated every 2 minutes was used for the procedure..
Other Names:
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Outcome Measures
Primary Outcome Measures
- Change in Keratometric indices [1 months]
The keratometric readings in the steepest and flattest meridians, along with the average K readings were compared pre and post treatment using conventional collagen cross linking technique at 1 month post cross linking.
Secondary Outcome Measures
- Improvement in vision [12 months]
Comparison of visual rehabilitation was done as improvements noted in Snellen line numbers and best corrected visual acuity (B.C.V.A) converted to decimals, pre and post treatment at 1,3,6,12 months post treatment.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients aged 18 years and below.
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Patients diagnosed to have keratoconus at presentation and willing for follow - up at regular intervals post treatment.
Exclusion Criteria:
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Any disease causing abnormal topography other than keratoconus.
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Any ocular condition predisposing towards poor vision (retinal , lens problems)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Vasan Eye Care Hospital | Chennai | Tamil Nadu | India | 600015 |
Sponsors and Collaborators
- Vasan Eye Care Hospital
Investigators
- Principal Investigator: Dr.Anand Parthasarathy, Vasan Eye Care Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- Caporossi A, Mazzotta C, Baiocchi S, Caporossi T, Denaro R, Balestrazzi A. Riboflavin-UVA-induced corneal collagen cross-linking in pediatric patients. Cornea. 2012 Mar;31(3):227-31.
- Chatzis N, Hafezi F. Progression of keratoconus and efficacy of pediatric [corrected] corneal collagen cross-linking in children and adolescents. J Refract Surg. 2012 Nov;28(11):753-8. doi: 10.3928/1081597X-20121011-01. Erratum in: J Refract Surg. 2013 Jan;29(1):72.
- Vinciguerra P, Albé E, Frueh BE, Trazza S, Epstein D. Two-year corneal cross-linking results in patients younger than 18 years with documented progressive keratoconus. Am J Ophthalmol. 2012 Sep;154(3):520-6. doi: 10.1016/j.ajo.2012.03.020. Epub 2012 May 24.
- PED_CXL