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Comparative evaluation of efficacy and safety of ophthalmic viscosurgical devices in phacoemulsification

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN34957881
Enrollment
56
Registered
2005-07-05
Start date
2004-01-05
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Senile Cataract Surgery Cataract

Interventions

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

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
The safety and efficacy of the three viscosurgical devices namely Viscoat®, Healon GV® and Healon 5® in performing phacoemulsification is comparable.

Secondary

MeasureTime frame
Viscoat® can result in a mild transient rise in the intraocular pressure.

Countries

India

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 13, 2026