Comparative evaluation of efficacy and safety of ophthalmic viscosurgical devices in phacoemulsification
| ISRCTN | ISRCTN34957881 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34957881 |
| Protocol serial number | N/A |
| Sponsor | All India Institute of Medical Sciences (AIIMS) (India) |
| Funder | All India Institute of Medical Sciences (AIIMS) (India) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure(s) |
The safety and efficacy of the three viscosurgical devices namely Viscoat®, Healon GV® and Healon 5® in performing phacoemulsification is comparable. |
| Key secondary outcome measure(s) |
Viscoat® can result in a mild transient rise in the intraocular pressure. |
| Completion date | 27/03/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
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 | 15/07/2005 | Yes | No |
