Efficacy of trypan blue in posterior capsulorhexis with optic capture in pediatric cataracts
| ISRCTN | ISRCTN48221688 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48221688 |
| Protocol serial number | N/A |
| Sponsor | Rajendra Prasad Centre for Ophthalmic Sciences (India) |
| Funder | Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS, New Delhi (India) |
- Submission date
- 02/09/2005
- Registration date
- 08/09/2005
- Last edited
- 03/10/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Rasik B Vajpayee
Scientific
Scientific
Rajendra Prasad Centre for Ophthalmic Sciences
All India Institute of Medical Sciences
New Delhi
110029
India
| rasikvajpayee@rediffmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Efficacy of trypan blue in posterior capsulorhexis with optic capture in pediatric cataracts: |
| Study objectives | Trypan blue staining helps to achieve good posterio capsulorhexis for optic capture in patients with pediatric cataracts: a randomised controlled trial |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Trypan blue |
| Primary outcome measure(s) |
Achievement of optic capture of posterior chamber intraocular lens. |
| Key secondary outcome measure(s) |
Good visual rehabilitation. |
| Completion date | 31/12/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | All |
| Target sample size at registration | 26 |
| Key inclusion criteria | Children with developmental or congenital cataract with visually significant lenticular opacity (3 mm or larger). |
| Key exclusion criteria | Eyes with traumatic cataract and associated ocular abnormalities were excluded. |
| Date of first enrolment | 01/01/2002 |
| Date of final enrolment | 31/12/2002 |
Locations
Countries of recruitment
- India
Study participating centre
Rajendra Prasad Centre for Ophthalmic Sciences
New Delhi
110029
India
110029
India
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | 16/03/2006 | Yes | No |
Editorial Notes
03/10/2017: internal review.
