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This clinical study is a controlled, open, prospective, single-centre, multi-surgeon eye study to determine the safety and efficacy of intraocular cuts for femtosecond laser assisted lens frag-mentation to support phacoemulsification of the cataractous lens prior to IOL implantation. The cuts are applied by means of the FEMTEC femtosecond laser system with the CustomLens soft-ware module using a cylindrical and radial cut pattern with diameter and height dependent on anterior chamber depth, pupil diameter and ocular lens size.
The hypothesis of the study is that by means of femtosecond laser assisted lens fragmentation the required ultrasound energy used for phacoemulsification can be reduced in a safe and effective way.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Femtec Groupe A | Experimental | In Group A the anterior capsulotomy and a pre-fragmentation of the ocular lens will be performed by means of femtosecond laser surgery |
|
| Manual Group B | Active Comparator | Group B acts as a control group where the capsulotomy and lens fragmentation are performed manually |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lens Fragmentation by means of a femtosecondlaser | Procedure | In Group A the anterior capsulotomy and a pre-fragmentation of the ocular lens will be performed by means of femtosecond laser surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Observation of the applied Effective Phaco Time (EPT) for Pahcoemulsifikation during surgery. The observed Effective Phaco Time in Group A should be significantly lower than in group B. Statistically significant difference at p<0.05. | at time of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Less or equal adverse events in Group A compared to group B (e.g. retinal detachment, IOL malposition). p<0.05 will be considered statistically significant. | 1-Day Follow-UP | |
| Less or equal severe adverse events in Group A compared to group B. p<0.05 will be considered statistically significant. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maxivision Eye Hospital | Hyderabad | Andhra Pradesh | 500082 | India |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| Manual Phacoemulsification | Procedure | Group B acts as a control group where the capsulotomy and lens fragmentation are performed manually |
|
| 1-Day Follow-UP |
| Easy of phacoemulsification as subjectively perceived by the surgeon during surgery | time fo surgery |