NCT01693575

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

September 19, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 26, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

April 16, 2015

Status Verified

September 1, 2012

Enrollment Period

2.3 years

First QC Date

September 19, 2012

Last Update Submit

April 15, 2015

Conditions

Miosis DisorderIntraoperative Floppy Iris Syndrome

Keywords

Small pupil cataract surgeryIntraoperative floppy iris syndrome (IFIS)

Outcome Measures

Primary Outcomes (1)

  • Efficacy of APX 100 device

    To assess the degree of pupil expansion by measuring the pupil diameter in millimeters after positioning the APX 100 device appropriately in small-pupil cataract surgery and in the management of intraoperative floppy iris syndrome (IFIS).

    6 months

Secondary Outcomes (1)

  • Safety of APX 100 device

    6 months

Study Arms (1)

Pupil expansion with APX 100 device

EXPERIMENTAL

Use of APX 100 device during standard phacoemulsification cataract extraction surgery in patients with small pupil diameter (\<4.5 mm) or with documented intraoperative floppy iris syndrome in previous eye.

Device: Pupil expansion with APX 100 device

Interventions

Pupil expansion with APX 100 deviceDEVICE

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.

Pupil expansion with APX 100 device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pupil diameter of less than 4.5 mm
  • Second eye cataract extraction operation with documented intraoperative floppy iris syndrome in the first eye, regardless of pupil diameter.

You may not qualify if:

  • Age under 18 years.
  • Only functional eye.
  • Active intraocular inflammation (uveitis).
  • Substantial iris defects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Medical Center

Kfar Saba, 44281, Israel

Location

MeSH Terms

Conditions

Miosis

Condition Hierarchy (Ancestors)

Pupil DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ehud Assia, M.D

    Meir Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2012

First Posted

September 26, 2012

Study Start

September 1, 2012

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

April 16, 2015

Record last verified: 2012-09

Locations

IL(1)