Condition category
Injury, Occupational Diseases, Poisoning
Date applied
04/06/2010
Date assigned
05/07/2010
Last edited
06/04/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

  1. 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.

Additional files

Editorial Notes