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11 February 2012
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| [ Print-friendly version ] |
| Umbilical cord serum therapy in acute ocular chemical burns |
| ISRCTN | ISRCTN08131903 |
| ClinicalTrials.gov identifier | |
| Public title | Umbilical cord serum therapy in acute ocular chemical burns |
| Scientific title | Evaluation of umbilical cord serum therapy in acute ocular chemical burns: a prospective, double-blind, randomised controlled trial |
| Acronym | N/A |
| Serial number at source | N/A |
| Study hypothesis |
The primary objectives of therapy in a case of acute ocular chemical burns are promotion of epithelialisation, reduction of inflammation, support of the reparative processes and prevention of complications. The standard medical treatment used in acute ocular chemical burns comprises of topical steroids, topical antibiotics, mydriatic cycloplegic, anti-glaucoma therapy, citrate and ascorbate. Autologous serum drops have been shown to be effective in the treatment of various ocular surface disorders including neurotrophic keratitis, severe dry eye, persistent epithelial defects and recurrent corneal erosions. Umbilical cord serum has been shown to be safe and effective in the treatment of neurotrophic keratitis, dry eye syndrome and persistent epithelial defects.
Both autologous serum and umbilical cord serum owe their efficacy to the presence of various growth factors like epidermal growth factor (EGF), acidic and basic fibroblast growth factor (FGF), platlet-derived growth factor, hepatocyte growth factor, vitamin A, transforming growth factor ß (TGF-ß), substance P, IGF-1 (insulin like growth factor-1), nerve growth factor (NGF), fibronectin and serum antiproteases such as a2 macroglobulin. The concentrations of EGF, TGF-ß and NGF are several times higher in umbilical cord serum than peripheral blood serum. In the present study we tested the hypothesis, that umbilical cord serum with its higher concentration of these growth factors may promote an early healing of the ocular surface in cases of chemical burns. |
| Lay summary | |
| Ethics approval | All India Institute of Medical Sciences, New Delhi, India approved on the 15th of September 2005 |
| Study design | Double blind prospective randomised controlled clinical trial |
| Countries of recruitment | India |
| Disease/condition/study domain | Acute chemical ocular burns |
| Participants - inclusion criteria |
1. Patients with acute ocular chemical burns (grade III, IV and V according to Dua classification) presenting within three weeks of injury
2. Either sex, aged 16 - 50 years |
| Participants - exclusion criteria |
1. Patients with grade I, II and VI injury
2. Impending perforation |
| Anticipated start date | 01/09/2005 |
| Anticipated end date | 01/07/2007 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please contact Dr Manik Goel [manikgoel_aiims99@yahoo.com] to request a patient information sheet |
| Target number of participants | 33 eyes of 32 patients |
| Interventions |
1. Patients were started on standard medical therapy consisting of:
1.1. Topical ofloxacin hydrochloride 0.3% 6-hourly 1.2. Topical prednisolone acetate 1% 2-hourly 1.3. Topical homatropine 2% three times daily (tds) 1.4. Topical ascorbate 10% 2-hourly 1.5. Topical citrate 10% 2-hourly 1.6. Oral vitamin C 500 mg four times daily (qid) 1.7. Preservative free topical lubricants 2-hourly 1.8. Topical anti-glaucoma medications (if required) in the form of timolol maleate eye drops 0.5% bid and/or oral acetazolamide 250 mg tds 2. Patients were then divided into three groups: 2.1. Group I received 20% umbilical cord serum drops 10 times a day 2.2. Group II received 20% autologous serum drops 10 times a day 2.3. Group III received artificial tear drops (0.5% hydroxypropylmethylcellulose and 0.3% glycerin) 10 times a day |
| Primary outcome measure(s) |
Patients were followed up on day 1, day 3, day 7, day 14, day 21 and at the end of 1 month, 2 months and 3 months. Total duration of follow up in all three groups was 3 months.
Parameters assessed were at each follow-up included: 1. Pain score 2. Best corrected visual acuity 3. Limbal ischaemia 4. Epithelial defect 5. Corneal clarity and vascularisation 6. Tear film status (Schirmer, TBUT) 7. Intraocular pressure (IOP) 8. Symblepharon formation |
| Secondary outcome measure(s) | Complications arising from injury and/or treatment |
| Sources of funding | Dr RP Centre for Ophthalmic Sciences (India) - Hospital infrastructure and resources |
| Trial website | |
| Publications | 1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/20538982 |
| Contact name | Prof Rasik Vajpayee |
| Address |
Centre for Eye Research Australia
University of Melbourne Royal Victorian Eye and Ear Hospital 32, Gisborne Street, East Melbourne Victoria |
| City/town | Melbourne |
| Zip/Postcode | 3002 |
| Country | Australia |
| rasikv@unimelb.edu.au | |
| Sponsor | Dr Rajendra Prasad Centre for Ophthalmic Sciences (India) |
| Address | Ansari Nagar |
| City/town | New Delhi |
| Zip/Postcode | 3002 |
| Country | India |
| rasikv@unimelb.edu.au | |
| Date applied | 04/06/2010 |
| Last edited | 06/04/2011 |
| Date ISRCTN assigned | 05/07/2010 |
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| © 2012 ISRCTN unless otherwise stated. | |
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