Umbilical cord serum therapy in acute ocular chemical burns

ISRCTN	ISRCTN08131903
DOI	https://doi.org/10.1186/ISRCTN08131903
Secondary identifying numbers	N/A

Submission date: 04/06/2010
Registration date: 05/07/2010
Last edited: 06/04/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Rasik Vajpayee
Scientific

Centre for Eye Research Australia
University of Melbourne
Royal Victorian Eye and Ear Hospital
32, Gisborne Street, East Melbourne
Victoria
Melbourne
3002
Australia

Email	rasikv@unimelb.edu.au

Study information

Study design	Double blind prospective randomised controlled clinical trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please contact Dr Manik Goel [manikgoel_aiims99@yahoo.com] to request a patient information sheet
Scientific title	Evaluation of umbilical cord serum therapy in acute ocular chemical burns: a prospective, double-blind, randomised controlled trial
Study objectives	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.
Ethics approval(s)	All India Institute of Medical Sciences, New Delhi, India approved on the 15th of September 2005
Health condition(s) or problem(s) studied	Acute chemical ocular burns
Intervention	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
Intervention type	Other
Primary outcome measure	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 measures	Complications arising from injury and/or treatment
Overall study start date	01/09/2005
Completion date	01/07/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	33 eyes of 32 patients
Key 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
Key exclusion criteria	1. Patients with grade I, II and VI injury 2. Impending perforation
Date of first enrolment	01/09/2005
Date of final enrolment	01/07/2007

Locations

Countries of recruitment

Australia
India

Study participating centre

Centre for Eye Research Australia

Melbourne
3002
Australia

Sponsor information

Dr Rajendra Prasad Centre for Ophthalmic Sciences (India)
Hospital/treatment centre

Ansari Nagar
New Delhi
3002
India

Email	rasikv@unimelb.edu.au
"ROR"	https://ror.org/02dwcqs71

Funders

Funder type

Hospital/treatment centre

Dr RP Centre for Ophthalmic Sciences (India) - Hospital infrastructure and resources

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	25/02/2011		Yes	No