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

NCT01693575 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2015-04-16

No results posted yet for this study

Summary

The purpose of the study is to gather clinical data and safety information on the use of APX 100 device for small-pupil cataract surgery and the management of intraoperative floppy iris syndrome (IFIS) during cataract surgery.

The APX 100, a FDA-approved device (510K exempt), is a disposable stainless steal sterile device for mechanical expansion of pupillary diameter during intraocular surgery. The APX 100 is inserted to the anterior chamber of the eye through standard clear corneal incisions. The device is then located on the pupil's border between the iris and the anterior lens capsule and the pupil's diameter is expanded.

The APX 100 will be used in standard phacoemulsification cataract extraction surgery when small pupil diameter (\<4.5 mm) is recognized preoperatively or develops intraoperatively due to IFIS.

Conditions

  • Miosis Disorder
  • Intraoperative 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.

Sponsors & Collaborators

  • Meir Medical Center

    lead OTHER

Principal Investigators

  • Ehud Assia, M.D · Meir Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01693575 on ClinicalTrials.gov