Ultrasound Cyclo Plasty in Eyes with Glaucoma
January 26th, 2018
Glaucoma is a chronic disease with progressive degeneration of optic nerve fibers resulting in decreased visual field. Elevated intraocular pressure is considered the most important and the only treatable risk factor. This manuscript describes a simple, surgeon-friendly, non-incisional technique, named Ultrasound Cyclo Plasty, for reducing intraocular pressure in glaucoma patients.
The overall goal of surgical protocol is to demonstrate a novel non-incisional surgical procedure that reduces intraocular pressure in glaucoma patients. The procedure determines the selective coagulation of the ciliary body by means of high intensity ultrasound beams while sparing the agent's structures. The technique is a safer, faster and less invasive, compared to traditional cycle destructive procedure, with more predictable results and less complications.
A crucial step of the procedure is the proper centering of the probe without moving, rotating or pushing it during the entire treatment. Begin preparing the treatment device by entering data about the surgeon and patient using the control unit touch screen then select the eye to treat. Next, open the sterile single-use device pack containing the coupling cone and the treatment probe and connect their cables to the control unit.
Disinfect the palpebral and periorbital skin with 10%povidone iodine 3x. Wipe the disinfected skin with clean sterile gauzes. Put a sterile surgical drape over the face of the patient with the central hole centered over the eye under treatment in order to properly expose it.
Next, place the patient's head slightly backwards in order to put the ocular surface horizontally allowing a comfortable placement of the cone of the device. Then, open the patient's eye without using the speculum. Put the coupling cone over the ocular surface with tubing on the temporal side and gently move it to correctly position and center it forming a uniform white scleral ring surrounding the limbus.
Push the aspiration button on the foot switch to start a low level suction from the peripheral ring of the coupling cone until the vertical bar on the screen becomes green. Next, insert the treatment probe inside the coupling cone with the cable in nasal position. Fill the empty space delimited by the eye, the cone and the probe with sterile balanced salt solution, or BSS, at room temperature at the beginning and during the entire procedure to allow good propagation of the therapeutic ultrasounds.
Refill at the appropriate level in case of BSS leakage. Next, ask the patient to hold the position and keep the head perfectly still then push the start button on the foot switch to start the treatment and hold the pressure during all the procedure. Firmly maintain the optimal position of the probe in the coupling cone during the entire procedure.
Avoid moving, rotating or pushing the probe in order to permit the best centering of therapeutic ultrasound beams during the treatment. At the end of the procedure, deactivate the suction system by pressing the aspiration button on the foot switch and slowly tilt the cone until BSS is removed through the tube. Finally, after surgery, instill antibiotic plus steroid drops in the treated eye immediately after the procedure and patch the treated eye for 24 hours.
Results indicate that the mean intraocular pressure, or IOP value, decreased compared to the preoperative value at each postoperative visit. Specifically, there was also a mean reduction of hypotensive eyedrops and oral acetozolamide tablets numbers over time. The procedure determines a significant reduction of intraocular pressure as well as the need for hypotensive eye drops or tablets.
The treatment is completely automated and standardized, lasts less than three minutes, and can be performed under locational anesthesia in outpatient setting. The procedure represent a step forward in the surgical treatment of glaucoma and provide ophthalmologist with a new minimally invasive option in the current therapy armamentarium. Future developments in the field of Sound Cyclo Plasty could allow treatments in term of ultrasound exposure with time in order to best allow treatment to each patients and eye.
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Overview
This article presents a novel, non-incisional surgical technique called Ultrasound Cyclo Plasty (UCP) for reducing intraocular pressure (IOP) in glaucoma patients. UCP utilizes high-intensity ultrasound beams to selectively coagulate the ciliary body, offering a safer, faster, and less invasive alternative to traditional cyclodestructive procedures. The method is automated, standardized, and can be performed under local anesthesia in an outpatient setting.
Key Study Components
Area of Science
- Ophthalmology
- Surgical techniques
- Medical device application
Background
- Glaucoma is a chronic disease characterized by progressive degeneration of optic nerve fibers, leading to visual impairment and potential blindness.
- Traditional cyclodestructive procedures to lower IOP are invasive and associated with complications.
- There is a need for safer, more predictable, and less invasive surgical options for glaucoma management.
- Ultrasound technology advancements have enabled more precise targeting of ocular structures.
Purpose of Study
- To demonstrate the feasibility and effectiveness of UCP as a non-incisional method for reducing IOP in glaucoma patients.
- To describe a standardized, surgeon-friendly protocol for UCP.
- To evaluate the safety, tolerability, and outcomes of UCP over a 12-month follow-up period.
Methods Used
- Preparation of the treatment device and patient data entry via control unit.
- Disinfection and draping of the ocular area.
- Placement and centering of a coupling cone and ultrasound probe over the eye.
- Filling the interface with sterile balanced salt solution to ensure ultrasound propagation.
- Sequential automatic activation of six piezoelectric transducers for less than 3 minutes.
- Postoperative care with antibiotic and steroid drops, and eye patching.
- Follow-up of 10 open-angle glaucoma patients for at least 12 months.
Main Results
- Mean IOP was reduced at each postoperative interval compared to preoperative values.
- There was a reduction in the number of hypotensive medications required post-procedure.
- 80% of patients responded to treatment; 20% required additional surgery for IOP control.
- No cases of hypotony or phthisis were observed, indicating good tolerability.
Conclusions
- UCP is a minimally invasive, efficient, and safe alternative to traditional cyclodestructive procedures for glaucoma.
- The technique offers predictable results with fewer complications and reduced need for medications.
- UCP expands the therapeutic options available to ophthalmologists for glaucoma management.
Frequently Asked Questions
Executive Industry Relevance
Ultrasound Cyclo Plasty (UCP) introduces a non-incisional, automated surgical modality for reducing intraocular pressure in glaucoma, addressing the need for safer and more predictable interventions. Its standardized, reproducible workflow and minimized invasiveness position UCP as a strategic advancement for device-enabled ophthalmic therapeutics. This technology supports portfolio expansion in minimally invasive glaucoma surgery and enhances confidence in early-stage device validation.
Strategic Applications in Biopharma R&D
Early Discovery & Target Validation
- Enables precise interrogation of ciliary body ablation as a therapeutic hypothesis for IOP reduction.
- Supports mechanistic de-risking by isolating ultrasound-mediated tissue effects from broader ocular damage.
- Facilitates functional validation of device-based interventions in disease-relevant models.
Screening & Assay Development
- Standardizes device setup and procedural steps for reproducible outcomes across operators.
- Generates quantitative IOP measurements for objective assessment of intervention efficacy.
- Prepares validated procedural protocols for downstream clinical device evaluation.
Translational & Preclinical Research
- Aligns with disease-relevant endpoints by targeting intraocular pressure in glaucoma models.
- Enables continuity from preclinical device testing to early clinical feasibility studies.
- Supports risk-adjusted advancement decisions based on tolerability and efficacy metrics.
Pipeline & Workflow Integration
UCP fits within the device discovery continuum from mechanistic validation through preclinical and early clinical evaluation, supporting iterative optimization and translational readiness.
- Discovery Biology: Provides a platform for hypothesis testing of ultrasound-mediated ciliary body ablation.
- Screening: Delivers reproducible, quantitative IOP reduction data for comparative analysis.
- Analytics: Enables standardized measurement of IOP and medication reduction as key readouts.
- Translational Research: Bridges preclinical device validation with clinical feasibility in glaucoma management.
- Enterprise Reuse: Establishes a reusable, automated protocol for future device-based ophthalmic interventions.
Operational & Enterprise Impact
- Scientific Value: Increases predictive confidence in device efficacy and safety for glaucoma.
- Operational Value: Streamlines procedure standardization and reproducibility across clinical sites.
- Strategic Value: Reduces late-stage biological risk and supports capital-efficient device development.
- Portfolio Impact: Informs risk-adjusted prioritization of minimally invasive ophthalmic devices.
Implementation Considerations
- Requires expertise in ophthalmic device handling and procedural standardization.
- Needs access to specialized ultrasound instrumentation and sterile surgical infrastructure.
- Demands rigorous cross-team training for reproducible probe placement and centering.
- Adaptation may be needed for different ocular anatomies or glaucoma subtypes.
- Limitations include non-responder rates and the need for subsequent interventions in some cases.
