Contact information
Type
Scientific
Primary contact
Dr Rasik B Vajpayee
ORCID ID
Contact details
Rajendra Prasad Centre for Ophthalmic Sciences
All India Institute of Medical Sciences
New Delhi
110029
India
-
rasikvajpayee@rediffmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Efficacy of trypan blue in posterior capsulorhexis with optic capture in pediatric cataracts:
Acronym
Study hypothesis
Trypan blue staining helps to achieve good posterio capsulorhexis for optic capture in patients with pediatric cataracts: a randomised controlled trial
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Cataracts
Intervention
Lens aspiration with posterior capsulorhexis with optic capture of intraocular lens with or without typan blue.
Intervention type
Drug
Phase
Not Applicable
Drug names
Trypan blue
Primary outcome measures
Achievement of optic capture of posterior chamber intraocular lens.
Secondary outcome measures
Good visual rehabilitation.
Overall trial start date
01/01/2002
Overall trial end date
31/12/2002
Reason abandoned
Eligibility
Participant inclusion criteria
Children with developmental or congenital cataract with visually significant lenticular opacity (3 mm or larger).
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
26
Participant exclusion criteria
Eyes with traumatic cataract and associated ocular abnormalities were excluded.
Recruitment start date
01/01/2002
Recruitment end date
31/12/2002
Locations
Countries of recruitment
India
Trial participating centre
Rajendra Prasad Centre for Ophthalmic Sciences
New Delhi
110029
India
Sponsor information
Organisation
Rajendra Prasad Centre for Ophthalmic Sciences (India)
Sponsor details
All India Institute of Medical Sciences (AIIMS)
New Delhi
110029
India
-
rvajpayee@rediffmail.com
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS, New Delhi (India)
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
2006 results in https://www.ncbi.nlm.nih.gov/pubmed/16539738
Publication citations
-
Results
Sharma N, Balasubramanya R, Dada VK, Vajpayee RB, Efficacy of trypan blue in posterior capsulorhexis with optic capture in pediatric cataracts [ISRCTN48221688]., BMC Ophthalmol, 2006, 6, 12, doi: 10.1186/1471-2415-6-12.