Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000305628
Ethics application status
Approved
Date submitted
9/02/2023
Date registered
17/03/2023
Date last updated
28/06/2023
Date data sharing statement initially provided
17/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
First in Human Study of the LensOne Device for the Support of a Posterior Chamber Intraocular Lens in the absence of capsular and zonular support
Scientific title
First in Human Study on safety and stability of the LensOne Device for the Support of a Posterior Chamber Intraocular Lens in the absence of capsular and zonular support
Secondary ID [1] 308820 0
CIP-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
In need of an IOL, but without sufficient capsular support (e.g. aphakic, dislocated lens, dislocated IOL). 328775 0
Condition category
Condition code
Eye 325783 325783 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study population includes subjects who would benefit from the implantation of an intraocular lens (IOL) and are not suitable for a posterior chamber IOL because of insufficient capsular and zonular support.

The LensOne is a sterile, non-optical ocular implant that is permanently inserted into the
posterior chamber of the eye during intraocular surgery. The device is intended to provide stable support for a posterior chamber intraocular lens in eyes that lack capsular and zonular support.
LensOne is suspended in the eye by three fixation arms which are trans-scleraly and subconjunctivally anchored. It has an internal cavity called the IOL housing designed to interact with the haptics of an IOL and securely envelope the IOL.

The LensOne device will be implanted during day surgery by a vitreoretinal surgeon after a screening visit. The surgery is expected to take approximately one hour and participants will be assessed post-operatively at 6 visits over 12 months.
Intervention code [1] 325267 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333627 0
Evaluate the safety of the LensOne device using;
- Slit lamp exam (Fluorescein conjunctival exam and photos)
- Dilated Fundus Examination,
- Intraocular pressure by Goldmann applanation tonometry (GAT)
- Optical Biometry
- Specular Microscopy
-Gonioscopy
- Pupillometry (photopic and mesopic)
- Visual Symptoms via McAlinden Quality of Vision (QoV) questionnaire
- corneal topography
- Posterior Optical Coherence Tomography (OCT)
- Ultrasound Biomicroscopy (Non dilated)
These tests will be assessed to provide a composite primary safety outcome
Timepoint [1] 333627 0
Day 1 post-surgery: Slit Lamp Exam, Dilated Fundus Examination, Intraocular Pressure (GAT) Anterior OCT and Uncorrected Visual Acuity
Day 7: as for Day 1 with addition of Best Corrected Visual Acuity with Manifest Refraction and Autorefraction
Week 4: as for day 1 with addition of Best Corrected Visual Acuity with Manifest Refraction, Autorefraction, Optical Biometry and Ultrasound Biomicroscopy (Non dilated).

3 months, 6 months and 12 months:
Slit lamp exam (Fluorescein conjunctival exam and photos), Dilated Fundus Examination, Intraocular pressure by Goldmann applanation tonometry (GAT), Optical Biometry, Specular Microscopy, Gonioscopy, Pupillometry (photopic and mesopic), Visual Symptoms via questionnaire, corneal topography, Posterior Optical coherence tomography (OCT), Ultrasound Biomicroscopy (Non dilated)
Primary outcome [2] 333628 0
Evaluate the stability of an IOL in the LensOne device by measurement of;

- IOL tilt by Anterior OCT (Dilated) or Purkinje and Scheimpflug imaging techniques and
- IOL decentration by Anterior OCT (Dilated)

Stability will be assessed as a composite of the Tilt and decentration results.
Timepoint [2] 333628 0
Day 1, Day 7, week 4, 3 months, 6 months, 12 months post-surgery
Secondary outcome [1] 417806 0
Evaluate best corrected visual acuity (BCVA) of study subjects with manifest refraction using Early Treatment Diabetic Retinopathy Study (ETDRS) chart at no less than 4 meters.
Timepoint [1] 417806 0
screening visit, day 7, week 4, 3 months, 6 months, 12 months post-surgery.
Secondary outcome [2] 419107 0
Evaluate Uncorrected Visual Acuity (UCVA) of study subjects with Early Treatment Diabetic Retinopathy Study (ETDRS) chart at no less than 4 meters.
Timepoint [2] 419107 0
screening visit, day 1, day 7, week 4, 3 months, 6 months, 12 months post-surgery.
Secondary outcome [3] 419108 0
Evaluation of refractive error in study subjects using autorefraction
Timepoint [3] 419108 0
Screening, day 7, week 4, 3 months, 6 months, 12 months post-surgery

Eligibility
Key inclusion criteria
1. In need of an IOL and without sufficient capsular support (e.g. aphakic, dislocated lens, dislocated IOL)
2. Ability to complete all required postoperative visits
3. White-to-white (WTW) of 11.0-13.0 mm as measured by optical biometry
4. Age: 50-85 years
5. Able to comprehend and provide informed consen
Minimum age
50 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

1. Corneal opacification precluding visualization of intraocular structures
2. Active retinal detachment or history of retinal detachment surgery within 12 months prior to Screening Visit
3. Active retinal vascular diseases
4. Active uveitis (infectious or non-infectious; anterior or posterior)
5. History of endophthalmitis
6. History of glaucoma filtering surgery
7. Need for concomitant glaucoma filtering surgery
8. Ciliary body cyst larger than 0.5 mm
9. Micro/nanophthalmos
10. Allergies to implant material, silicone
11. Active alcohol or narcotic dependence
12. Psychiatric illness preventing reliable follow up

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Non-randomised trial
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
All statistical analyses of safety and performance measures will be descriptive in nature. Continuous variables will be summarized by a mean, standard deviation, minimum, median and maximum, and categorical variables by a count and percentage. Confidence intervals (CIs) will be provided where relevant.
No formal sample size calculation has been performed, and the sample size is empirical. However, the sample size of 35 subjects is considered sufficient to adequately characterize the general safety profile and performance of LensOne device.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/04/2023
Actual
31/05/2023
Date of last participant enrolment
Anticipated
12/04/2024
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
35
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 313043 0
Commercial sector/Industry
Name [1] 313043 0
Long Bridge Medical Pty Ltd
Country [1] 313043 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Long Bridge Medial Pty Ltd
Address
58 Gipps Street
Collingwood VIC 3066
Country
Australia
Secondary sponsor category [1] 314728 0
None
Name [1] 314728 0
Address [1] 314728 0
Country [1] 314728 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312296 0
Bellberry
Ethics committee address [1] 312296 0
Ethics committee country [1] 312296 0
Australia
Date submitted for ethics approval [1] 312296 0
18/01/2023
Approval date [1] 312296 0
07/03/2023
Ethics approval number [1] 312296 0
2023-01-042

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124150 0
A/Prof Mathew Simunivic
Address 124150 0
Save Sight Institute, Macula Research Group,
Level 1, 8 Macquarie St
Sydney NSW 2000
Country 124150 0
Australia
Phone 124150 0
+61 2 9382 7309
Fax 124150 0
Email 124150 0
[email protected]
Contact person for public queries
Name 124151 0
Matthew Clarke
Address 124151 0
Long Bridge Medical Inc.
6000 Shoreline Ct. Ste. 206
South San Francisco, CA 94080 USA
Country 124151 0
United States of America
Phone 124151 0
+1 310 922 3609
Fax 124151 0
Email 124151 0
[email protected]
Contact person for scientific queries
Name 124152 0
Matthew Clarke
Address 124152 0
Long Bridge Medical Inc.
6000 Shoreline Ct. Ste. 206
South San Francisco, CA 94080 USA
Country 124152 0
United States of America
Phone 124152 0
+1 310 922 3609
Fax 124152 0
Email 124152 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
At this time there is no plan to submit IPD however, should this change, this record will be updated.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.