Condition category
Surgery
Date applied
18/06/2005
Date assigned
05/07/2005
Last edited
19/02/2008
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

Prof Rasik Vajpayee

ORCID ID

Contact details

R. P. Centre
AIIMS
Ansari Nagar
New Delhi
110029
India

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Ophthalmic viscosurgical devices

Study hypothesis

To compare the efficacy and safety of three ophthalmic viscosurgical devices that are routinely used in phacoemulsification.

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

Not specified

Trial type

Treatment

Patient information sheet

Condition

Senile Cataract

Intervention

Comparing three viscosurgical devices namely Viscoat®, Healon GV® and Healon 5® in performing phacoemulsification.

Intervention type

Device

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

05/01/2004

Overall trial end date

27/03/2004

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

56

Participant 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

Recruitment start date

05/01/2004

Recruitment end date

27/03/2004

Locations

Countries of recruitment

India

Trial participating centre

R. P. Centre
New Delhi
110029
India

Sponsor information

Organisation

All India Institute of Medical Sciences (AIIMS) (India)

Sponsor details

R. P. Centre
Ansari Nagar
New Delhi
110029
India

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

All India Institute of Medical Sciences (AIIMS) (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

Results in http://www.ncbi.nlm.nih.gov/pubmed/16018819

Publication citations

  1. Results

    Vajpayee RB, Verma K, Sinha R, Titiyal JS, Pandey RM, Sharma N, Comparative evaluation of efficacy and safety of ophthalmic viscosurgical devices in phacoemulsification [ISRCTN34957881]., BMC Ophthalmol, 2005, 5, 17, doi: 10.1186/1471-2415-5-17.

Additional files

Editorial Notes