Comparative evaluation of efficacy and safety of ophthalmic viscosurgical devices in phacoemulsification
| ISRCTN | ISRCTN34957881 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34957881 |
| Secondary identifying numbers | N/A |
- Submission date
- 18/06/2005
- Registration date
- 05/07/2005
- Last edited
- 19/02/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Rasik Vajpayee
Scientific
Scientific
R. P. Centre
AIIMS
Ansari Nagar
New Delhi
110029
India
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | Ophthalmic viscosurgical devices |
| Study objectives | To compare the efficacy and safety of three ophthalmic viscosurgical devices that are routinely used in phacoemulsification. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Senile Cataract |
| Intervention | Comparing three viscosurgical devices namely Viscoat®, Healon GV® and Healon 5® in performing phacoemulsification. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | The safety and efficacy of the three viscosurgical devices namely Viscoat®, Healon GV® and Healon 5® in performing phacoemulsification is comparable. |
| Secondary outcome measures | Viscoat® can result in a mild transient rise in the intraocular pressure. |
| Overall study start date | 05/01/2004 |
| Completion date | 27/03/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 56 |
| Key inclusion criteria | 1. More than 40 years of age 2. Senile cataract 3. Nucleus hardness of grade 3/4 4. Not having any evidence of subluxation or pseudoexfoliation 5. Not having any other associated ocular pathology |
| Key exclusion criteria | Pre-existing glaucoma and intraoperative events like manual dilatation of pupil, posterior capsular rent and placement of intraocular lens (IOL) in the sulcus |
| Date of first enrolment | 05/01/2004 |
| Date of final enrolment | 27/03/2004 |
Locations
Countries of recruitment
- India
Study participating centre
R. P. Centre
New Delhi
110029
India
110029
India
Sponsor information
All India Institute of Medical Sciences (AIIMS) (India)
University/education
University/education
R. P. Centre
Ansari Nagar
New Delhi
110029
India
"ROR" |
https://ror.org/02dwcqs71 |
|---|
Funders
Funder type
University/education
All India Institute of Medical Sciences (AIIMS) (India)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 | 15/07/2005 | Yes | No |
