Cataract SurgeryNCT07343973
Post-Market Study on the Safety and Effectiveness of the OpHLINE OVD in Cataract Surgery
A study testing Cataract Surgery by Phacoemulsification with Posterior Chamber Intraocular Lens Implantation (OpHLINE 1.4%), Cataract Surgery by Phacoemulsification with Posterior Chamber Intraocular Lens Implantation (OpHLINE 2%) and Cataract Surgery by Phacoemulsification with Posterior Chamber Intraocular Lens Implantation (OpHLINE 3%) in people with Cataract Surgery, run by i+Med S.Coop. at 2 sites in Spain.
Trial summary
This post-market clinical study was designed to assess the safety and effectiveness of the OpHLINE Ophthalmic Viscosurgical Device (OVD) as an adjunct in cataract surgery. OpHLINE is a sterile, viscoelastic solution based on high-molecular-weight sodium hyaluronate, intended to maintain the anterior chamber space and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract Surgery
- What is being tested?
- Cataract Surgery by Phacoemulsification with Posterior Chamber Intraocular Lens Implantation (OpHLINE 1.4%), Cataract Surgery by Phacoemulsification with Posterior Chamber Intraocular Lens Implantation (OpHLINE 2%) and Cataract Surgery by Phacoemulsification with Posterior Chamber Intraocular Lens Implantation (OpHLINE 3%)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 2 sitesSpain
- Study dates
- 2 Mar 2021to 14 Sep 2022
- 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
- Adults aged 18 years or older scheduled for cataract extraction by phacoemulsification, followed by implantation of a posterior chamber intraocular lens (IOL) in a single eye (operative eye).
- The non-operative eye must be functional, as assessed by the investigator.
Who cannot join
- Ocular hypertension (IOP ≥ 22 mmHg).
- Corneal endothelial damage (cell count < 2000 cells/mm²).
- History of chronic or recurrent ocular inflammatory disease.
- Chronic or recurrent uveitis.
- Acute ocular disease.
- Internal or external ocular infection.
Show all 11Show fewer
- Glaucoma or proliferative diabetic retinopathy.
- Previous ocular trauma before surgery.
- Congenital ocular anomalies or iris atrophy.
- Any other ocular pathology or physiological condition that could be worsened by cataract surgery.
- Previous ocular surgery.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Basurto University Hospital
Bilbao, Bizkaia, 48013
Araba University Hospital
Vitoria-Gasteiz, Álava, 01009
About this study
Official title: Post-Market Study for the Evaluation of the Efficacy and Safety of the OpHLINE Ophthalmic Viscosurgical Device (OVD) in Cataract Surgery
This post-market clinical study was designed to assess the safety and effectiveness of the OpHLINE Ophthalmic Viscosurgical Device (OVD) as an adjunct in cataract surgery. OpHLINE is a sterile, viscoelastic solution based on high-molecular-weight sodium hyaluronate, intended to maintain the anterior chamber space and protect corneal endothelial cells during phacoemulsification and intraocular lens (IOL) implantation.
The hypothesis is that OpHLINE, available in three concentrations (1.4%, 2%, and 3%), will provide optimal space maintenance throughout all surgical phases-capsulorhexis, hydrodissection, phacoemulsification, and IOL insertion-while ensuring ease of removal and minimizing postoperative complications. Specifically, the study expects the device to demonstrate high biocompatibility, effective protection of corneal endothelial cells, and a low incidence of adverse events, including intraocular pressure (IOP) spikes.
The objectives include confirming compliance with current clinical performance standards and collecting surgeons' feedback on handling and usability. This evaluation aims to strengthen real-world evidence supporting OpHLINE as a safe and reliable solution for cataract surgery, ensuring patient safety and surgical efficiency.
- Conditions
- Cataract Surgery
- Being tested
- Cataract Surgery by Phacoemulsification with Posterior Chamber Intraocular Lens Implantation (OpHLINE 1.4%), Cataract Surgery by Phacoemulsification with Posterior Chamber Intraocular Lens Implantation (OpHLINE 2%), Cataract Surgery by Phacoemulsification with Posterior Chamber Intraocular Lens Implantation (OpHLINE 3%)
- Keywords
- Hyaluronic acid, Ophtalmic viscosurgical device, Cataract surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cataract Surgery by Phacoemulsification with Posterior Chamber Intraocular Lens Implantation (OpHLINE 1.4%)Device
Eligible patients underwent cataract removal by phacoemulsification, followed by implantation of a posterior chamber intraocular lens (IOL) in a single eye.
The surgical procedure included the following steps:
Capsulorhexis: creation of a continuous circular opening in the anterior capsule of the lens.
Hydrodissection: injection of fluid to separate the capsule from the cortex. Phacoemulsification: ultrasonic fragmentation and aspiration of the opacified lens through a micro-incision.
IOL insertion: placement of the intraocular lens in the posterior chamber.
OpHLINE 1.4% OVD was used as an adjunct during these phases to maintain the anterior chamber space and protect ocular tissues. After lens implantation, the viscoelastic device were aspirated according to standard surgical practice.
Cataract Surgery by Phacoemulsification with Posterior Chamber Intraocular Lens Implantation (OpHLINE 2%)Device
Eligible patients underwent cataract removal by phacoemulsification, followed by implantation of a posterior chamber intraocular lens (IOL) in a single eye.
The surgical procedure included the following steps:
Capsulorhexis: creation of a continuous circular opening in the anterior capsule of the lens.
Hydrodissection: injection of fluid to separate the capsule from the cortex. Phacoemulsification: ultrasonic fragmentation and aspiration of the opacified lens through a micro-incision.
IOL insertion: placement of the intraocular lens in the posterior chamber.
OpHLINE 2% OVD was used as an adjunct during these phases to maintain the anterior chamber space and protect ocular tissues. After lens implantation, the viscoelastic device were aspirated according to standard surgical practice.
Cataract Surgery by Phacoemulsification with Posterior Chamber Intraocular Lens Implantation (OpHLINE 3%)Device
Eligible patients underwent cataract removal by phacoemulsification, followed by implantation of a posterior chamber intraocular lens (IOL) in a single eye.
The surgical procedure included the following steps:
Capsulorhexis: creation of a continuous circular opening in the anterior capsule of the lens.
Hydrodissection: injection of fluid to separate the capsule from the cortex. Phacoemulsification: ultrasonic fragmentation and aspiration of the opacified lens through a micro-incision.
IOL insertion: placement of the intraocular lens in the posterior chamber.
OpHLINE 3% OVD was used as an adjunct during these phases to maintain the anterior chamber space and protect ocular tissues. After lens implantation, the viscoelastic device were aspirated according to standard surgical practice.
| Study group | Role | What they receive |
|---|---|---|
| OpHLINE® 1.4% | Experimental | Patients undergoing cataract surgery received the OpHLINE OVD with 1.4% sodium hyaluronate. This formulation is designed to maintain the anterior chamber space and protect corneal endothelial cells while offering easier removal due to its lower viscosity. Receives: Device: Cataract Surgery by Phacoemulsification with Posterior Chamber Intraocular Lens Implantation (OpHLINE 1.4%) |
| OpHLINE® 2% | Experimental | Patients in this group were treated with the OpHLINE OVD containing 2% sodium hyaluronate. This intermediate concentration aims to provide enhanced space stability during surgical phases while balancing protection and handling characteristics. Receives: Device: Cataract Surgery by Phacoemulsification with Posterior Chamber Intraocular Lens Implantation (OpHLINE 2%) |
| OpHLINE® 3% | Experimental | This group received the OpHLINE OVD with 3% sodium hyaluronate, the highest concentration tested. It is intended to maximize space maintenance and tissue protection during surgery, though it may require more effort for removal due to its higher viscosity. Receives: Device: Cataract Surgery by Phacoemulsification with Posterior Chamber Intraocular Lens Implantation (OpHLINE 3%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to maintain anterior chamber space during cataract surgery.
This outcome evaluates whether the OpHLINE OVD can maintain a stable and adequate anterior chamber throughout all critical phases of cataract surgery: capsulorhexis, hydrodissection, phacoemulsification, and intraocular lens (IOL) insertion. Surgeons assessed this parameter using a structured questionnaire, classifying the chamber status into four categories: Complete chamber, Adequate working space, Shallow chamber, and Flat. A positive outcome is defined as achieving either a complete chamber or adequate working space in at least 70% of cases. This measure reflects the core functionality of the OVD in providing surgical safety and facilitating precise maneuvers.
Measured: 90 days
Safety evaluation of OpHLINE during and after surgery
This measure involves systematic monitoring and documentation of any serious adverse events related to the device during the entire study period. SAEs include any event that could result in significant harm or require medical intervention. The target is an incidence rate of ≤1%, confirming that the device does not introduce unexpected risks beyond those inherent to cataract surgery.
Measured: 90 days
Secondary outcomes (4)
Assessment of removal difficulty after IOL implantation
Surgeons classify removal as Easy, Normal, or Problematic. Adequate removal is defined as Easy or Normal in at least 70% of cases
Measured: 6 hours
Percentage of endothelial cell density loss
Endothelial cell density was measured using a non-contact specular microscope at baseline and at 90 days post-surgery. The goal is to determine the protective effect of the OVD on corneal tissue during surgery. A loss of ≤12% is considered optimal, as excessive cell loss can compromise corneal transparency and visual outcomes.
Measured: 90 days
Incidence of IOP ≥30 mmHg during follow-up
IOP was measured at all scheduled visits to monitor postoperative pressure changes. The target is ≤13% incidence at 6 hours post-surgery and ≤6% at subsequent visits. Elevated IOP (>30 mmHg) can lead to optic nerve damage if not controlled, so this measure ensures the device does not contribute to clinically significant pressure spikes.
Measured: 90 days
Frequency of non-serious adverse events during follow-up
This includes any minor complications or events that occur during or after surgery, such as mild inflammation or transient discomfort. The acceptable threshold is ≤30% across the study period, aligning with typical postoperative profiles for cataract surgery.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start2 Mar 2021
- Primary completion14 Sep 2022
- Study completion14 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cataract SurgeryStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- i+Med S.Coop.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital Universitario Araba, Hospital Universitario Basurto
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07343973
- Sponsor's protocol ID
- OpHLINE-PIC01-2020
- Status last verified
- Jan 2026
- First submitted
- 7 Jan 2026
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Melero A, Torrecilla J, Pino A, Alonso JM, Coello D, Saez de Arregui S, Garay-Aramburu G, Lopez-Plandolit S, Guergue O, Henares I, Huguet-Casquero A, Ucelay Lopez de Heredia M, Perez Gonzalez R. Hyaluronic acid concentration predictably modulates physicochemical properties and clinical performance in ophthalmic viscosurgical devices: integrated laboratory and prospective clinical assessment. BMC Ophthalmol. 2026 May 20;26(1):414. doi: 10.1186/s12886-026-04924-4.
PubMed 42163257
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Study for the Evaluation of the Efficacy and Safety of the OpHLINE Ophthalmic Viscosurgical Device (OVD) in Cataract Surgery
- ClinicalTrials.gov ID
- NCT07343973
- Acronym / sponsor ID
- OpHLINE-PIC01-2020
- Conditions
- Cataract Surgery
- Keywords
- Hyaluronic acid, Ophtalmic viscosurgical device, Cataract surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- i+Med S.Coop.Industry (pharma, biotech, devices)
- Collaborators
- Hospital Universitario Araba, Hospital Universitario Basurto
- Study start
- 2 Mar 2021 (actual)
- Primary completion
- 14 Sep 2022 (actual)
- Study completion
- 14 Sep 2022 (actual)
- First posted
- 15 Jan 2026 (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 post-market clinical study was designed to assess the safety and effectiveness of the OpHLINE Ophthalmic Viscosurgical Device (OVD) as an adjunct in cataract surgery. OpHLINE is a sterile, viscoelastic solution based on high-molecular-weight sodium hyaluronate, intended to maintain the anterior chamber space and protect corneal endothelial cells during phacoemulsification and intraocular lens (IOL) implantation.
The hypothesis is that OpHLINE, available in three concentrations (1.4%, 2%, and 3%), will provide optimal space maintenance throughout all surgical phases-capsulorhexis, hydrodissection, phacoemulsification, and IOL insertion-while ensuring ease of removal and minimizing postoperative complications. Specifically, the study expects the device to demonstrate high biocompatibility, effective protection of corneal endothelial cells, and a low incidence of adverse events, including intraocular pressure (IOP) spikes.
The objectives include confirming compliance with current clinical performance standards and collecting surgeons' feedback on handling and usability. This evaluation aims to strengthen real-world evidence supporting OpHLINE as a safe and reliable solution for cataract surgery, ensuring patient safety and surgical efficiency.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| OpHLINE® 1.4% | Experimental | Device: Cataract Surgery by Phacoemulsification with Posterior Chamber Intraocular Lens Implantation (OpHLINE 1.4%)Patients undergoing cataract surgery received the OpHLINE OVD with 1.4% sodium hyaluronate. This formulation is designed to maintain the anterior chamber space and protect corneal endothelial cells while offering easier removal due to its lower viscosity. |
| OpHLINE® 2% | Experimental | Device: Cataract Surgery by Phacoemulsification with Posterior Chamber Intraocular Lens Implantation (OpHLINE 2%)Patients in this group were treated with the OpHLINE OVD containing 2% sodium hyaluronate. This intermediate concentration aims to provide enhanced space stability during surgical phases while balancing protection and handling characteristics. |
| OpHLINE® 3% | Experimental | Device: Cataract Surgery by Phacoemulsification with Posterior Chamber Intraocular Lens Implantation (OpHLINE 3%)This group received the OpHLINE OVD with 3% sodium hyaluronate, the highest concentration tested. It is intended to maximize space maintenance and tissue protection during surgery, though it may require more effort for removal due to its higher viscosity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults aged 18 years or older scheduled for cataract extraction by phacoemulsification, followed by implantation of a posterior chamber intraocular lens (IOL) in a single eye (operative eye).
- The non-operative eye must be functional, as assessed by the investigator.
Key exclusion criteria (11 listed)
- Ocular hypertension (IOP ≥ 22 mmHg).
- Corneal endothelial damage (cell count < 2000 cells/mm²).
- History of chronic or recurrent ocular inflammatory disease.
- Chronic or recurrent uveitis.
- Acute ocular disease.
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 |
|---|---|---|
| Cataract Surgery by Phacoemulsification with Posterior Chamber Intraocular Lens Implantation (OpHLINE 1.4%)Eligible patients underwent cataract removal by phacoemulsification, followed by implantation of a posterior chamber intraocular lens (IOL) in a single eye. The surgical procedure included the following steps: Capsulorhexis: creation of a continuous circular opening in the anterior capsule of the lens. Hydrodissection: injection of fluid to separate the capsule from the cortex. Phacoemulsification: ultrasonic fragmentation and aspiration of the opacified lens through a micro-incision. IOL insertion: placement of the intraocular lens in the posterior chamber. OpHLINE 1.4% OVD was used as an adjunct during these phases to maintain the anterior chamber space and protect ocular tissues. After lens implantation, the viscoelastic device were aspirated according to standard surgical practice. | Device | OpHLINE® 1.4% |
| Cataract Surgery by Phacoemulsification with Posterior Chamber Intraocular Lens Implantation (OpHLINE 2%)Eligible patients underwent cataract removal by phacoemulsification, followed by implantation of a posterior chamber intraocular lens (IOL) in a single eye. The surgical procedure included the following steps: Capsulorhexis: creation of a continuous circular opening in the anterior capsule of the lens. Hydrodissection: injection of fluid to separate the capsule from the cortex. Phacoemulsification: ultrasonic fragmentation and aspiration of the opacified lens through a micro-incision. IOL insertion: placement of the intraocular lens in the posterior chamber. OpHLINE 2% OVD was used as an adjunct during these phases to maintain the anterior chamber space and protect ocular tissues. After lens implantation, the viscoelastic device were aspirated according to standard surgical practice. | Device | OpHLINE® 2% |
| Cataract Surgery by Phacoemulsification with Posterior Chamber Intraocular Lens Implantation (OpHLINE 3%)Eligible patients underwent cataract removal by phacoemulsification, followed by implantation of a posterior chamber intraocular lens (IOL) in a single eye. The surgical procedure included the following steps: Capsulorhexis: creation of a continuous circular opening in the anterior capsule of the lens. Hydrodissection: injection of fluid to separate the capsule from the cortex. Phacoemulsification: ultrasonic fragmentation and aspiration of the opacified lens through a micro-incision. IOL insertion: placement of the intraocular lens in the posterior chamber. OpHLINE 3% OVD was used as an adjunct during these phases to maintain the anterior chamber space and protect ocular tissues. After lens implantation, the viscoelastic device were aspirated according to standard surgical practice. | Device | OpHLINE® 3% |
Primary outcome
Ability to maintain anterior chamber space during cataract surgery.
Time frame: 90 days
This outcome evaluates whether the OpHLINE OVD can maintain a stable and adequate anterior chamber throughout all critical phases of cataract surgery: capsulorhexis, hydrodissection, phacoemulsification, and intraocular lens (IOL) insertion. Surgeons assessed this parameter using a structured questionnaire, classifying the chamber status into four categories: Complete chamber, Adequate working space, Shallow chamber, and Flat. A positive outcome is defined as achieving either a complete chamber or adequate working space in at least 70% of cases. This measure reflects the core functionality of the OVD in providing surgical safety and facilitating precise maneuvers.
Safety evaluation of OpHLINE during and after surgery
Time frame: 90 days
This measure involves systematic monitoring and documentation of any serious adverse events related to the device during the entire study period. SAEs include any event that could result in significant harm or require medical intervention. The target is an incidence rate of ≤1%, confirming that the device does not introduce unexpected risks beyond those inherent to cataract surgery.
4 secondary outcomes
Assessment of removal difficulty after IOL implantation
Time frame: 6 hours
Percentage of endothelial cell density loss
Time frame: 90 days
Incidence of IOP ≥30 mmHg during follow-up
Time frame: 90 days
Frequency of non-serious adverse events during follow-up
Time frame: 90 days
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 11 Feb 2026.
- Derived from this study: PubMed 42163257Melero A, Torrecilla J, Pino A, Alonso JM, Coello D, Saez de Arregui S, Garay-Aramburu G, Lopez-Plandolit S, Guergue O, Henares I, Huguet-Casquero A, Ucelay Lopez de Heredia M, Perez Gonzalez R. Hyaluronic acid concentration predictably modulates physicochemical properties and clinical performance in ophthalmic viscosurgical devices: integrated laboratory and prospective clinical assessment. BMC Ophthalmol. 2026 May 20;26(1):414. doi: 10.1186/s12886-026-04924-4.
- Individual participant dataSharing planned: No
Related trials for Cataract Surgery
Not yet recruiting
Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
Aphakia, Postcataract
Not yet recruiting
Effects of Oxygen Cage Support During Cataract Surgery
Cataract
RecruitingObservational study
Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments
Light Adjustable Lens, Objective Depth of Focus
RecruitingObservational study
Anterior Segment Anatomy Assessed by Swept-Source OCT in Ocular Surgery Patients
Cataract, Primary Angle-Closure Glaucoma
RecruitingObservational study
Surgical Procedure Efficiency Evaluation stuDy
Cataract, Vitreous Hemorrhage
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cataract Surgery by Phacoemulsification with Posterior Chamber Intraocular Lens Implantation (OpHLINE 1.4%), Cataract Surgery by Phacoemulsification with Posterior Chamber Intraocular Lens Implantation (OpHLINE 2%) and Cataract Surgery by Phacoemulsification with Posterior Chamber Intraocular Lens Implantation (OpHLINE 3%) in people with Cataract Surgery, run by i+Med S.Coop. at 2 sites in Spain.
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 11 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 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
Ability to maintain anterior chamber space during cataract surgery. (time frame: 90 days). 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?
On the ClinicalTrials.gov record for NCT07343973, which also lists 1 linked publication.
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 11 Feb 2026.