Contact information
Type
Scientific
Primary contact
Prof Rasik Vajpayee
ORCID ID
Contact details
Centre for Eye Research Australia
University of Melbourne
Royal Victorian Eye and Ear Hospital
32
Gisborne Street
East Melbourne
Victoria
Melbourne
3002
Australia
rasikv@unimelb.edu.au
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Evaluation of umbilical cord serum therapy in acute ocular chemical burns: a prospective, double-blind, randomised controlled trial
Acronym
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.
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please contact Dr Manik Goel [manikgoel_aiims99@yahoo.com] to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
01/09/2005
Overall trial end date
01/07/2007
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
33 eyes of 32 patients
Participant exclusion criteria
1. Patients with grade I, II and VI injury
2. Impending perforation
Recruitment start date
01/09/2005
Recruitment end date
01/07/2007
Locations
Countries of recruitment
India
Trial participating centre
Centre for Eye Research Australia
Melbourne
3002
Australia
Sponsor information
Organisation
Dr Rajendra Prasad Centre for Ophthalmic Sciences (India)
Sponsor details
Ansari Nagar
New Delhi
3002
India
rasikv@unimelb.edu.au
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Dr RP Centre for Ophthalmic Sciences (India) - Hospital infrastructure and resources
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/20538982
Publication citations
-
Results
Sharma N, Goel M, Velpandian T, Titiyal JS, Tandon R, Vajpayee RB, Evaluation of umbilical cord serum therapy in acute ocular chemical burns., Invest. Ophthalmol. Vis. Sci., 2011, 52, 2, 1087-1092, doi: 10.1167/iovs.09-4170.