Femtosecond Laser Assisted Cataract Surgery in Intumescent Cataracts
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 7/14/2016 |
| Start Date: | March 2015 |
| End Date: | August 2016 |
The purpose of the study is to compare femtosecond laser-assisted capsulotomy to manual
capsulorhexis in patients with intumescent cataracts. An intumescent cataract is defined as
a cataract with a pressurized capsular bag.
capsulorhexis in patients with intumescent cataracts. An intumescent cataract is defined as
a cataract with a pressurized capsular bag.
Inclusion Criteria:
- Willing to undergo cataract surgery.
- Able to lie flat in a supine position.
- Able to understand and willing to sign the Informed Consent Form (ICF).
- Presenting with intumescent white cataract, with a liquid pressurized bag and a
milky, liquid cortex.
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
- Pregnant or lactating mothers.
- Corneal disease that precludes application of the cornea or transmission of laser
light at 1030 nanometer (nm) wavelength.
- Corneal opacity that would interfere with the laser beam.
- Presence of blood or other material in the anterior chamber.
- Hypotony or presence of corneal implant.
- Poorly dilating pupils.
- Condition which would cause inadequate clearance between the intended capsulotomy
depth and the endothelium.
- Residual, recurrent, active ocular or eye lid disease, including any corneal
abnormality.
- Any contraindication to cataract surgery.
- Other protocol-specified exclusion criteria may apply.
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