Prospective Evaluation of Circularity and Diameter of Femtosecond Laser Versus Manual Anterior Capsulotomy in Singapore National Eye Centre (1118)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Technolas Perfect Vision GmbH
ClinicalTrials.gov Identifier:
NCT01693211
First received: September 14, 2012
Last updated: June 30, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Primary Disease: Cataract
Device: Femtosecond Laser (VICTUS™ Femtosecond Laser Platform)
Device: Manual (CCC technique with Utrata forceps)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Evaluation of Circularity and Diameter of Femtosecond Laser Versus Manual Anterior Capsulotomy in Singapore National Eye Centre

Resource links provided by NLM:


Further study details as provided by Technolas Perfect Vision GmbH:

Primary Outcome Measures:
  • Circularity of created rhexis [ Time Frame: intraoperative ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Diameter of the created rhexis [ Time Frame: intraoperative ] [ Designated as safety issue: No ]
    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. On the day of surgery immediately after the creation of the rhexis via an recorded surgical video.


Other Outcome Measures:
  • Centration of the created rhexis relative to the pupil [ Time Frame: surgery day, 1-Day, 1-week, 1-Month ] [ Designated as safety issue: No ]
    The additional outcome is to determine if the centration of the created rhexis relative to the pupil 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 and postoperative (1-Day, 1-week, 1-Month) based on slit lamp pictures.


Enrollment: 48
Study Start Date: September 2012
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Capsulorhexis and pre-fragmentation of the nucleus are performed by the femtosecond laser.
Device: Femtosecond Laser (VICTUS™ Femtosecond Laser Platform)
Capsulotomy and pre-fragmentation of the nucleus are performed by the femtosecond laser.
Active Comparator: Group B
The Capulorhexis and nuclear fragmentation are performed manually.
Device: Manual (CCC technique with Utrata forceps)
Capsulorhexis and pre-fragmentation are performed manually.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01693211

Locations
Singapore
Singapore National Eye Centre
Singapore, Singapore, 168751
Sponsors and Collaborators
Technolas Perfect Vision GmbH
Investigators
Principal Investigator: Soon Phaik Chee, Assoc Prof Singapore National Eye Center
  More Information

Additional Information:
No publications provided

Responsible Party: Technolas Perfect Vision GmbH
ClinicalTrials.gov Identifier: NCT01693211     History of Changes
Other Study ID Numbers: 1118
Study First Received: September 14, 2012
Last Updated: June 30, 2014
Health Authority: Singapore: Health Sciences Authority

Keywords provided by Technolas Perfect Vision GmbH:
femtosecond laser
cataract
control study
prospective

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on September 16, 2014