NCT01693211

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Technolas Perfect Vision GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This clinical study is a controlled, open, randomized, prospective, single-centre, single-surgeon eye study to determine the precision of intraocular cuts for anterior capsulotomy in connection to cataract surgery and IOL implantation. The cuts are applied by means of the VICTUS femtosecond laser system using a cylindrical cut pattern with diameter and height dependent on anterior chamber depth, pupil diameter and ocular lens size for Group A and the manual surgery technique for Group B. The allocation of the surgery technique will be randomized between the study patient. Each surgery technique represents a study group. In Group A the anterior capsulotomy and lens fragmentation will be performed by means of femtosecond laser surgery. Group B acts as a control group where the capsulotomy as well as the lens fragmentation is performed manually. The hypothesis of the study is that by means of intraocular, laser-induced cuts, circularity of the capsulotomy can be improved in a safe and effective way. A detailed pre-operative examination will ensure that every interested and willing patient fulfils the inclusion criteria of this study. Post-operative examinations, which should document the success of the treatment, are to be carried out after 1-day, 1-week, 1-month.

Conditions

• Primary Disease: Cataract

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-09-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2012-09-26
• Last updated: 2014-07-01

Locations

1 site across 1 country: Singapore