Condition category
Eye Diseases
Date applied
02/09/2005
Date assigned
08/09/2005
Last edited
03/10/2007
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

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

Acronym

Study hypothesis

Trypan blue staining helps to achieve good posterio capsulorhexis for optic capture in patients with pediatric cataracts.

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 Specified

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

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16539738&query_hl=1&itool=pubmed_DocSum

Publication citations

  1. 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.

Additional files

Editorial Notes