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Prospective Evaluation of Circularity and Diameter of Femtosecond Laser Versus Manual Anterior Capsulotomy in Singapore National Eye Centre

NCT01693211 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2014-07-01

No results posted yet for this study

Summary

This is a prospective, randomized study evaluating the circularity of the anterior capsulotomy performed by the VICTUS femtosecond work station (Group A) versus the manual capsulotomy (Group B) of a minimum of 22 eyes and maximum of 30 eyes per group diagnosed with cataract, scheduled to undergo removal by phacoemulsification with intraocular lens implantation in SNEC.

The primary study end point is to determine if the circularity of the created rhexis is better in Group A as compared to Group B.

The secondary study end point is to determine the diameter of rhexis is more precise and reproducible in Group A as compared to Group B.

Conditions

  • Primary Disease: Cataract

Interventions

DEVICE

Femtosecond Laser (VICTUS™ Femtosecond Laser Platform)

Capsulotomy and pre-fragmentation of the nucleus are performed by the femtosecond laser.

DEVICE

Manual (CCC technique with Utrata forceps)

Capsulorhexis and pre-fragmentation are performed manually.

Sponsors & Collaborators

  • Technolas Perfect Vision GmbH

    lead INDUSTRY

Principal Investigators

  • Soon Phaik Chee, Assoc Prof · Singapore National Eye Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01693211 on ClinicalTrials.gov