Miosis DisorderNCT01693575
Use of APX 100 Device for Small-pupil Cataract Surgery and Intraoperative Floppy-iris Syndrome
A study testing Pupil expansion with APX 100 device in people with Miosis Disorder and Intraoperative Floppy Iris Syndrome, run by Meir Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Miosis Disorder, Intraoperative Floppy Iris Syndrome
- What is being tested?
- Pupil expansion with APX 100 device
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2012to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Age under 18 years.
- Only functional eye.
- Active intraocular inflammation (uveitis).
- Substantial iris defects
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of APX 100 Device for Expansion of Small Pupil in Cataract Surgery and Management of Intraoperative Floppy-iris Syndrome
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.
Read the detailed description
In cases of small-pupil cataract surgery and intraoperative floppy iris syndrome (IFIS) the potential of intraoperative complications is substantial. The risk of posterior lens capsule tear, dropped nucleus fragments and vitreous loss increases.
There are several surgical methods and commercial products designed to deal with small pupil diameter in ocular surgery. Among these, pupil viscodilation with ophthalmic viscosurgical devices, mechanical dilation of pupil with ocular spatula, radial incisions in pupil's sphincter and iris retractors (iris hooks, Malyugin ring, Perfect Pupil ring), are the most popular. Each method has its advantages and disadvantages.
Our group developed an innovative iris retractor device named APX 100. It is a disposable stainless steal sterile device designed for mechanical expansion of pupillary diameter during intraocular surgery. The device was approved by the FDA (510K exempt) for iris retraction in small pupil diameters and in IFIS. It comes in a disposable kit with 2 iris retractors and 2 forceps.
The study was designed to help us gain more clinical knowledge about the surgical advantages and safety of APX 100 beyond registration data.
Patients designated for standard phacoemulsification cataract extraction with small pupil diameter or with documented IFIS in previous eye will be enrolled to the study. The APX 100 will be used intraoperatively in order to retract the iris and expand the pupil. All other cataract extraction surgical stages will remain unchanged.
The study includes five study visits: preoperative examination, cataract extraction surgery, first postoperative day, 1 week postoperatively, 1 month postoperatively. All data regarding the intraoperative use of the device and its effect on ocular tissues and final visual acuity will be documented in the patients' files.
The preoperative visit will include a thorough eye examination, visual acuity test, intraocular pressure measurement, subjective refraction, measurements to decide the intraocular lens power, endothelial cell counts, corneal topography and anterior segment photography. The second visit will be the cataract extraction surgery itself during which the APX 100 device will be used. On the first postoperative day visual acuity will be tested, intraocular pressure will be measured, a thorough eye examination will be performed and treatment with topical third-generation fluoroquinolone antibiotics and corticosteroids drops will be initiated. Examination one week postoperatively will be the same as in the previous visit, only the topical treatment regimen will be changed - topical antibiotics will be stopped and the dosage of the corticosteroids drops will be lowered and maintained for additional three weeks. The last study visit, 1 month postoperatively, will include subjective refraction, best corrected visual acuity, a thorough eye examination, intraocular pressure measurement, endothelial cell counts, corneal topography and anterior segment photography.
- Being tested
- Pupil expansion with APX 100 device
- Keywords
- Small pupil cataract surgery, Intraoperative floppy iris syndrome (IFIS)
- Medical subject headings
- Miosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Pupil expansion with APX 100 device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months
Secondary outcomes (1)
Safety of APX 100 device
To assess the rate of the possible adverse effects on ocular tissues (cornea, iris, lens and ciliary body) by the use of APX 100 device.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Miosis DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ehud Assia, M.D, Principal investigator, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01693575
- Sponsor's protocol ID
- APX-2012MMC
- Status last verified
- Sep 2012
- First submitted
- 19 Sep 2012
- Last updated
- 16 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of APX 100 Device for Expansion of Small Pupil in Cataract Surgery and Management of Intraoperative Floppy-iris Syndrome
- ClinicalTrials.gov ID
- NCT01693575
- Acronym / sponsor ID
- APX-2012MMC
- Keywords
- Small pupil cataract surgery, Intraoperative floppy iris syndrome (IFIS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 26 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In cases of small-pupil cataract surgery and intraoperative floppy iris syndrome (IFIS) the potential of intraoperative complications is substantial. The risk of posterior lens capsule tear, dropped nucleus fragments and vitreous loss increases.
There are several surgical methods and commercial products designed to deal with small pupil diameter in ocular surgery. Among these, pupil viscodilation with ophthalmic viscosurgical devices, mechanical dilation of pupil with ocular spatula, radial incisions in pupil's sphincter and iris retractors (iris hooks, Malyugin ring, Perfect Pupil ring), are the most popular. Each method has its advantages and disadvantages.
Our group developed an innovative iris retractor device named APX 100. It is a disposable stainless steal sterile device designed for mechanical expansion of pupillary diameter during intraocular surgery. The device was approved by the FDA (510K exempt) for iris retraction in small pupil diameters and in IFIS. It comes in a disposable kit with 2 iris retractors and 2 forceps.
The study was designed to help us gain more clinical knowledge about the surgical advantages and safety of APX 100 beyond registration data.
Patients designated for standard phacoemulsification cataract extraction with small pupil diameter or with documented IFIS in previous eye will be enrolled to the study. The APX 100 will be used intraoperatively in order to retract the iris and expand the pupil. All other cataract extraction surgical stages will remain unchanged.
The study includes five study visits: preoperative examination, cataract extraction surgery, first postoperative day, 1 week postoperatively, 1 month postoperatively. All data regarding the intraoperative use of the device and its effect on ocular tissues and final visual acuity will be documented in the patients' files.
The preoperative visit will include a thorough eye examination, visual acuity test, intraocular pressure measurement, subjective refraction, measurements to decide the intraocular lens power, endothelial cell counts, corneal topography and anterior segment photography. The second visit will be the cataract extraction surgery itself during which the APX 100 device will be used. On the first postoperative day visual acuity will be tested, intraocular pressure will be measured, a thorough eye examination will be performed and treatment with topical third-generation fluoroquinolone antibiotics and corticosteroids drops will be initiated. Examination one week postoperatively will be the same as in the previous visit, only the topical treatment regimen will be changed - topical antibiotics will be stopped and the dosage of the corticosteroids drops will be lowered and maintained for additional three weeks. The last study visit, 1 month postoperatively, will include subjective refraction, best corrected visual acuity, a thorough eye examination, intraocular pressure measurement, endothelial cell counts, corneal topography and anterior segment photography.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pupil expansion with APX 100 device | Experimental | Device: Pupil expansion with APX 100 deviceUse 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- Age under 18 years.
- Only functional eye.
- Active intraocular inflammation (uveitis).
- Substantial iris defects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pupil expansion with APX 100 devicePatients 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. | Device | Pupil expansion with APX 100 device |
Primary outcome
Efficacy of APX 100 device
Time frame: 6 months
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).
1 secondary outcome
Safety of APX 100 device
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ehud Assia, M.D principal investigator
Meir Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pupil expansion with APX 100 device in people with Miosis Disorder and Intraoperative Floppy Iris Syndrome, run by Meir Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of APX 100 device (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2015.