Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Capsulorhexis and pre-fragmentation of the nucleus are performed by the femtosecond laser. |
|
| Group B | Active Comparator | The Capulorhexis and nuclear fragmentation are performed manually. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Femtosecond Laser (VICTUSâ„¢ Femtosecond Laser Platform) | Device | Capsulotomy and pre-fragmentation of the nucleus are performed by the femtosecond laser. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Soon Phaik Chee, Assoc Prof | Singapore National Eye Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Singapore National Eye Centre | Singapore | Singapore | 168751 | Singapore |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Manual (CCC technique with Utrata forceps) | Device | Capsulorhexis and pre-fragmentation are performed manually. |
|
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided