Clinical trial NCT01693211: Prospective Evaluation of Circularity and Diameter of Femtosecond Laser Versus Manual Anterior Capsulotomy in Singapore National Eye Centre
Official title: Prospective Evaluation of Circularity and Diameter of Femtosecond Laser Versus Manual Anterior Capsulotomy in Singapore National Eye Centre
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Disease: Cataract
Keywords: femtosecond laser
cataract
control study
prospective
Lead sponsor: Technolas Perfect Vision GmbH
Sponsor class: INDUSTRY
First posted: 2012-09-26
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Circularity of created rhexis
timeFrame: intraoperative
Secondary outcomes:
measure: Diameter of the created rhexis
timeFrame: intraoperative
Other outcomes:
measure: Centration of the created rhexis relative to the pupil
timeFrame: surgery day, 1-Day, 1-week, 1-Month
Locations:
city: Singapore
country: Singapore
facility: Singapore National Eye Centre
Study officials:
affiliation: Singapore National Eye Center
name: Soon Phaik Chee, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
References: