Use of APX 100 Device for Small-pupil Cataract Surgery and Intraoperative Floppy-iris Syndrome

NACompletedINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

September 30, 2012

Primary Completion Date

January 31, 2015

Study Completion Date

January 31, 2015

Conditions
Miosis DisorderIntraoperative Floppy Iris Syndrome
Interventions
DEVICE

Pupil expansion with APX 100 device

Patients with small pupils (\<4.5 mm) that would not dilate pharmacologically or small pupils that develop intraoperatively due to intraoperative floppy iris syndrome (IFIS) will be assigned to APX 100 device intervention during standard phacoemulsification cataract surgery. After creating two standard clear corneal incisions in the horizontal meridians, two APX 100 retractors will be inserted to the anterior chamber of the eye 180 degrees apart with special forceps, one retractor at a time, and will be located on the pupil's border between the iris and the anterior lens capsule. Then, the devices will be released from the forceps and the pupil diameter will expand. The next steps of the surgery will remain unchanged. After the implantation of the intraocular lens (IOL) in the capsular bag the APX 100 retractors will be removed the same way as inserted. The clear corneal incisions will then be closed by hydration.

Trial Locations (1)

44281

Meir Medical Center, Kfar Saba

Sponsors
All Listed Sponsors
lead

Meir Medical Center

OTHER