Pars Plana VitrectomyPhase 1NCT05592912
Safety and Efficacy of HydroLenz for Vitrectomy-Induced Lens Opacities
A Phase 1 study testing HydroLenz Injection and No HydroLenz Injection in people with Pars Plana Vitrectomy, run by PromiSight, LLC.
Trial summary
The primary objective of this study is to provide safety data for two different dosages of HydroLenz. Secondary objectives are to provide preliminary data to determine whether HydroLenz has the same effect in humans as it does in the porcine model; to confirm the reliability of methods for evaluating lens opacity… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Pars Plana Vitrectomy
- What is being tested?
- HydroLenz Injection and No HydroLenz Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 1 Jan 2025
- Phase
- Phase 1
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Male or female of any race.
- 65 years of age or older.
- Study eye is phakic and scheduled for pars plana vitrectomy (23, 25, or 27 gauge) for epiretinal membrane or vitreomacular traction surgery.
- Willingness and ability to comply with schedule for follow-up visits.
- Subject understands the study requirements and the treatment procedures and provides signed, written informed consent obtained in accordance with the institutional review board (or ethics committee) requirements for this first-in-man early feasibility study.
Who cannot join
- Aphakic or pseudophakic lens status in either or both eyes.
- History of previous cataract surgery in either eye.
- Evidence of congenital cataract.
- Study eye with corneal opacity of one of the following LOCS III grades or condition that would confound the LOCS III grading results:
- Inability to grade opacities in the study eye with LOCS III at the baseline exam;
- Inability to dilate pupil to at least 6.0 mm;
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- LOCS III grade ≥ 2 for nuclear opalescence, cortical lens opacities, or posterior subcapsular lens opacities in the study eye at baseline.
- Diabetic retinopathy or macular edema in the study eye.
- Retinal vascular disease or retinopathy in the study eye.
- History of previous intravitreal injections in the study eye.
- History of previous subconjunctival injections in the study eye.
- History of previous radiation in the study eye.
- History of systemic, periocular, inhaled, or chronic topical corticosteroids.
- Previous laser prophylaxis for retinal tear/hole/lattice degeneration in the study eye.
- Previous pneumatic retinopexy or retinal detachment repair in the study eye.
- Previous vitrectomy in the study eye.
- Previous laser treatment anywhere in the study eye (trabecular meshwork, iris, retina, macula).
- Use of silicone oil, air or gas tamponade during the vitrectomy in the study eye prior to injection of the HydroLenz.
- Use of binocular indirect ophthalmoscopy laser during the procedure (endolaser is permitted).
- History of any previous ocular surgery in the study eye.
- Any ocular trauma resulting in lens opacity or subluxation of the lens in the study eye.
- Iatrogenic lens trauma during surgery prior to injection of the HydroLenz.
- Surgical plan for the vitrectomy includes planned glaucoma filtering or tube-shunt procedure or any procedure affecting the lens.
- Female patients who are pregnant or lactating or plan to become pregnant during the course of the study.
- A known sensitivity to study medications for which no alternative medication can be - prescribed.
- Presence or history of any other condition or finding that, in the investigator's opinion, makes the patient unsuitable as a candidate for the HydroLenz treatment or study participation or may confound the outcome of the study.
About this study
Official title: Safety and Preliminary Efficacy of Two Dose Levels of HydroLenz as a Protectant for Vitrectomy-Induced Lens Opacities in Subjects Undergoing Vitrectomy
The primary objective of this study is to provide safety data for two different dosages of HydroLenz. Secondary objectives are to provide preliminary data to determine whether HydroLenz has the same effect in humans as it does in the porcine model; to confirm the reliability of methods for evaluating lens opacity; and, to acquire information that can be used to design the pivotal study.
- Conditions
- Pars Plana Vitrectomy
- Being tested
- HydroLenz Injection, No HydroLenz Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydroLenz InjectionDrug
The HydroLenz injection will be administered at the conclusion of the vitrectomy procedure on the operative day
No HydroLenz InjectionOther
No HydroLenz injection will be administered at the conclusion of the vitrectomy procedure on the operative day.
| Study group | Role | What they receive |
|---|---|---|
| Low dose HydroLenz treatment | Experimental | Not described Receives: Drug: HydroLenz Injection |
| High dose HydroLenz treatment | Experimental | Not described Receives: Drug: HydroLenz Injection |
| Control, i.e., no HydroLenz treatment | Placebo comparator | Not described Receives: Other: No HydroLenz Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Changes in Lens Opacities
The Lens Opacity Classification System, Version III (LOCS III) and the rate of lens related (cataract) surgery will be used to evaluate the lens opacities.
Measured: Baseline and 6 Months
Evaluation of Changes in Lens Opacities
The Lens Opacity Classification System, Version III (LOCS III) and the rate of lens related (cataract) surgery will be used to evaluate the lens opacities.
Measured: Baseline and 12 Months
Changes in BSCVA
Number of eyes losing more than 2 lines of BSCVA
Measured: Baseline and 6 Months
Changes in BSCVA
Number of eyes losing more than 2 lines of BSCVA
Measured: Baseline and 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2022
- Study start1 Jan 2024 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Why it stopped: Funding Limitations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pars Plana VitrectomyStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- PromiSight, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05592912
- Sponsor's protocol ID
- HL-001
- Status last verified
- Jul 2025
- First submitted
- 18 Oct 2022
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Preliminary Efficacy of Two Dose Levels of HydroLenz as a Protectant for Vitrectomy-Induced Lens Opacities in Subjects Undergoing Vitrectomy
- ClinicalTrials.gov ID
- NCT05592912
- Acronym / sponsor ID
- HL-001
- Conditions
- Pars Plana Vitrectomy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding Limitations
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PromiSight, LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 25 Oct 2022 (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.
The primary objective of this study is to provide safety data for two different dosages of HydroLenz. Secondary objectives are to provide preliminary data to determine whether HydroLenz has the same effect in humans as it does in the porcine model; to confirm the reliability of methods for evaluating lens opacity; and, to acquire information that can be used to design the pivotal study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose HydroLenz treatment | Experimental | Drug: HydroLenz Injection |
| High dose HydroLenz treatment | Experimental | Drug: HydroLenz Injection |
| Control, i.e., no HydroLenz treatment | Placebo comparator | Other: No HydroLenz Injection |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Male or female of any race.
- 65 years of age or older.
- Study eye is phakic and scheduled for pars plana vitrectomy (23, 25, or 27 gauge) for epiretinal membrane or vitreomacular traction surgery.
- Willingness and ability to comply with schedule for follow-up visits.
- Subject understands the study requirements and the treatment procedures and provides signed, written informed consent obtained in accordance with the institutional review board (or ethics committee) requirements for this first-in-man early feasibility study.
Key exclusion criteria (26 listed)
- Aphakic or pseudophakic lens status in either or both eyes.
- History of previous cataract surgery in either eye.
- Evidence of congenital cataract.
- Study eye with corneal opacity of one of the following LOCS III grades or condition that would confound the LOCS III grading results:
- Diabetic retinopathy or macular edema in the study eye.
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 |
|---|---|---|
| HydroLenz InjectionThe HydroLenz injection will be administered at the conclusion of the vitrectomy procedure on the operative day | Drug | High dose HydroLenz treatment, Low dose HydroLenz treatment |
| No HydroLenz InjectionNo HydroLenz injection will be administered at the conclusion of the vitrectomy procedure on the operative day. | Other | Control, i.e., no HydroLenz treatment |
Primary outcome
Evaluation of Changes in Lens Opacities
Time frame: Baseline and 6 Months
The Lens Opacity Classification System, Version III (LOCS III) and the rate of lens related (cataract) surgery will be used to evaluate the lens opacities.
Evaluation of Changes in Lens Opacities
Time frame: Baseline and 12 Months
The Lens Opacity Classification System, Version III (LOCS III) and the rate of lens related (cataract) surgery will be used to evaluate the lens opacities.
Changes in BSCVA
Time frame: Baseline and 6 Months
Number of eyes losing more than 2 lines of BSCVA
Changes in BSCVA
Time frame: Baseline and 12 Months
Number of eyes losing more than 2 lines of BSCVA
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HydroLenz Injection and No HydroLenz Injection in people with Pars Plana Vitrectomy, run by PromiSight, LLC.
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 5 inclusion and 26 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: withdrawn, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Evaluation of Changes in Lens Opacities (time frame: Baseline and 6 Months). The study lists 4 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 25 Jul 2025.