Aphakia, AcquiredNCT03437434
Scleral Fixation of BunnyLens With GoreTex Suture- Initial Results
An observational study of Aphakia, Acquired, run by DAVID HAUSER at 1 site in Israel.
Trial summary
This study evaluates the Visual Acuity and refraction of patients post 4-point Scleral fixation of BunnyLens (Intra Ocular Lens- IOL) with GoreTex sutures. All patients underwent secondary IOL implantation or IOL exchange during 2014-2017. Read more about this study
- Who is it for?
- Ages 15 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Aphakia, Acquired
- What is being tested?
- Visual Acuity
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- 24 Apr 2017to 24 Apr 2018
- Phase
- Observational
- 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 15 to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients who are capable of inform consent and are eligible according to the inclusion criteria.
Who may be able to join
- patients that underwent secondary cataract surgery or IOL replacement and BunnyLens fixation with Gore-Tex sutures.
Who cannot join
- Lack of Cooperation, death, severe physical or mental illness, patient's request to withdraw of the clinical trial.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Barzilai University Medical Center
Ashkelon, 7830604
Ornit Cohen, M.Med.Sc, 972 8 6746146, ornitc@bmc.gov.il
About this study
Official title: Gore-Tex Suture and BunnyLens Scleral Fixation - Historical Retrospective Trial
This study evaluates the Visual Acuity and refraction of patients post 4-point Scleral fixation of BunnyLens (Intra Ocular Lens- IOL) with GoreTex sutures. All patients underwent secondary IOL implantation or IOL exchange during 2014-2017.
Read the detailed description
4 point scleral fixation of PC- IOL (Posterior Chamber-PC) BunnyLens with Gore-Tex sutures is a surgical technique for implanting IOL in patients with capsular support absence, due to trauma, abnormal anterior chamber, IOL dislocation, or ciliary zonule defect.
The 4 point fixation enables to align the PC- IOL with minimal vertical and horizontal deviation;The Gore-Tex sutures maintain stable scleral fixation with no suture erosion or breakage.
- Conditions
- Aphakia, Acquired
- Being tested
- Visual Acuity
- Medical subject headings
- Aphakia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual AcuityOther
Also called Refraction, Biomicroscopy
Ocular Examination
| Study group | Role | What they receive |
|---|---|---|
| BunnyLens and Gore-Tex suture | All patients Underwent 4 point PC-IOL scleral fixation with Gore-Tex sutures Receives: Other: Visual Acuity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance Visual Acuity
Degree of Visual Acuity is measured in LogMar (-0.3 to1) and by Decimal Value (0.0-2.0)
Measured: Up to 24 months from surgery.
Ocular Refraction
Refraction of the Ocular surfaces, measured in sphere, cylinder and axis.
Measured: Up to 24 months from surgery.
Secondary outcomes (1)
Slit Lamp Biomicroscopy
Slit lamp examination of the anterior and posterior segments.
Measured: Up to 24 months from surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start24 Apr 2017
- Primary completion24 Mar 2018 (estimated)
- Study completion24 Apr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aphakia, AcquiredStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DAVID HAUSER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, DAVID HAUSER, Barzilai Medical Center
- Investigators
- David Hauser, MD, Principal investigator, Barzilai University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03437434
- Sponsor's protocol ID
- 114-16-BRZ
- Status last verified
- Feb 2018
- First submitted
- 21 Jan 2018
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gore-Tex Suture and BunnyLens Scleral Fixation - Historical Retrospective Trial
- ClinicalTrials.gov ID
- NCT03437434
- Acronym / sponsor ID
- 114-16-BRZ
- Conditions
- Aphakia, Acquired
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- DAVID HAUSERUniversity, hospital or other
- Study start
- 24 Apr 2017 (actual)
- Primary completion
- 24 Mar 2018 (estimated)
- Study completion
- 24 Apr 2018 (estimated)
- First posted
- 19 Feb 2018 (actual)
- 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.
This study evaluates the Visual Acuity and refraction of patients post 4-point Scleral fixation of BunnyLens (Intra Ocular Lens- IOL) with GoreTex sutures. All patients underwent secondary IOL implantation or IOL exchange during 2014-2017.
Detailed description
4 point scleral fixation of PC- IOL (Posterior Chamber-PC) BunnyLens with Gore-Tex sutures is a surgical technique for implanting IOL in patients with capsular support absence, due to trauma, abnormal anterior chamber, IOL dislocation, or ciliary zonule defect.
The 4 point fixation enables to align the PC- IOL with minimal vertical and horizontal deviation;The Gore-Tex sutures maintain stable scleral fixation with no suture erosion or breakage.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BunnyLens and Gore-Tex suture | – | Other: Visual AcuityAll patients Underwent 4 point PC-IOL scleral fixation with Gore-Tex sutures |
Who may qualify
- Ages
- 15 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who are capable of inform consent and are eligible according to the inclusion criteria.
Key inclusion criteria (1 listed)
- patients that underwent secondary cataract surgery or IOL replacement and BunnyLens fixation with Gore-Tex sutures.
Key exclusion criteria (1 listed)
- Lack of Cooperation, death, severe physical or mental illness, patient's request to withdraw of the clinical trial.
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 |
|---|---|---|
| Visual AcuityAlso: Refraction, BiomicroscopyOcular Examination | Other | BunnyLens and Gore-Tex suture |
Primary outcome
Distance Visual Acuity
Time frame: Up to 24 months from surgery.
Degree of Visual Acuity is measured in LogMar (-0.3 to1) and by Decimal Value (0.0-2.0)
Ocular Refraction
Time frame: Up to 24 months from surgery.
Refraction of the Ocular surfaces, measured in sphere, cylinder and axis.
1 secondary outcome
Slit Lamp Biomicroscopy
Time frame: Up to 24 months from surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
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.
David Hauser, MD principal investigator
Barzilai University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aphakia, Acquired, run by DAVID HAUSER 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 Feb 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Hauser, MD (972-526700010, dehauser@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distance Visual Acuity (time frame: Up to 24 months from surgery.). The study lists 2 primary outcomes in all. 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 19 Feb 2018.