Primary Disease: Cataract Clinical Trial
— 1118Official title:
Prospective Evaluation of Circularity and Diameter of Femtosecond Laser Versus Manual Anterior Capsulotomy in Singapore National Eye Centre
| Verified date | June 2014 |
| Source | Technolas Perfect Vision GmbH |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Singapore: Health Sciences Authority |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 48 |
| Est. completion date | June 2014 |
| Est. primary completion date | June 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Singapore | Singapore National Eye Centre | Singapore |
| Lead Sponsor | Collaborator |
|---|---|
| Technolas Perfect Vision GmbH |
Singapore,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Centration of the created rhexis relative to the pupil | 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. | surgery day, 1-Day, 1-week, 1-Month | No |
| Primary | 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 | No |
| Secondary | Diameter of the created rhexis | 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. | intraoperative | No |