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

NCT01693211 | Completed

• 1 other identifier: 1118
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Disease: Cataract

Keywords

femtosecond laser; cataract; control study; prospective

Outcome Measures

Primary Outcomes (1)

• Circularity of created rhexis

  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. On the day of surgery immediately after the creation of the rhexis via an recorded surgical video.

  intraoperative

Secondary Outcomes (1)

• Diameter of the created rhexis

  intraoperative

Other Outcomes (1)

• Centration of the created rhexis relative to the pupil

  surgery day, 1-Day, 1-week, 1-Month

Study Arms (2)

Group A

EXPERIMENTAL

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

Device: Femtosecond Laser (VICTUS™ Femtosecond Laser Platform)

Group B

ACTIVE COMPARATOR

The Capulorhexis and nuclear fragmentation are performed manually.

Device: Manual (CCC technique with Utrata forceps)

Interventions

Femtosecond Laser (VICTUS™ Femtosecond Laser Platform) DEVICE

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

Group A

Manual (CCC technique with Utrata forceps) DEVICE

Capsulorhexis and pre-fragmentation are performed manually.

Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Technolas Perfect Vision GmbH: lead

Study Sites (1)

Singapore National Eye Centre

Singapore, Singapore, 168751, Singapore

Location

Related Links

• Sponsor

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Soon Phaik Chee, Assoc Prof

  Singapore National Eye Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2012
• First Posted: September 26, 2012
• Study Start: September 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: July 1, 2014

Record last verified: 2014-06

Locations

SG (1)