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

NCT ID: NCT01693211

Last Updated: 2014-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2014-06-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

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

Group Type: EXPERIMENTAL

Femtosecond Laser (VICTUS™ Femtosecond Laser Platform)

Intervention Type: DEVICE

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

Group B

The Capulorhexis and nuclear fragmentation are performed manually.

Group Type: ACTIVE_COMPARATOR

Manual (CCC technique with Utrata forceps)

Intervention Type: DEVICE

Capsulorhexis and pre-fragmentation are performed manually.

Interventions

Femtosecond Laser (VICTUS™ Femtosecond Laser Platform)

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

Intervention Type: DEVICE

Manual (CCC technique with Utrata forceps)

Capsulorhexis and pre-fragmentation are performed manually.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Consenting patients undergoing phacoemulsification and IOL implant surgery for cataract, the diagnosis of which has been confirmed by another investigator.
• Clear cornea media
• Pupil must be able to dilate to at least 6mm in diameter measured with the pupil gauge

Exclusion Criteria

• Pre-existing posterior capsule rupture Difference between maximum and minimum K-values must not be more than 5 D. The maximum K- value may not exceed 60 D and the minimal value may not be smaller than 37 D.
• Corneal disease or pathology that precludes transmission of laser wavelength or distortion of laser light.
• Subjects with a poorly dilating pupil or other defect of the pupil that prevents the iris from adequate retraction peripherally.
• Lens/zonular instability such as, but not restricted to, Marfan's Syndrome, Pseudoexfoliation Syndrome, etc.
• Previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes in either eye.
• Patients with disorders of the ocular muscle, such as nystagmus or strabismus Keratoconus
• ACD < 1.8 mm or ACD > 4.5 mm

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Technolas Perfect Vision GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Soon Phaik Chee, Assoc Prof

Role: PRINCIPAL_INVESTIGATOR

Singapore National Eye Center

Locations

Singapore National Eye Centre

Singapore, Singapore, Singapore

Countries

Singapore

Related Links

http://www.technolaspv.com/

Sponsor

Other Identifiers

1118

Identifier Type: -

Identifier Source: org_study_id