HOLDER

Dispositivo de Anclaje Escleral

para soporte de lente intraocular

For Investigational Use

NUEVA TÉCNICA

IMPLANTE DE LIO

SIN SOPORTE CAPSULAR

The Holder is a modular artificial capsular support system. It enables safe, universal intraocular lens (IOL) implantation—including premium toric and multifocal lenses—in eyes lacking adequate natural capsular support.

The Clinical Challenge

Absence or profound weakness of capsular support obligates the use of secondary IOL fixation techniques.

Limitations of Current Techniques

  • Scleral or iris fixation primarily accommodates 3-piece monofocal lenses.
  • Yamane and similar techniques fixate the IOL haptics directly, limiting future adjustability or safe IOL exchange.

A Conceptual Shift: Artificial Capsular Platform

Rather than fixating the lens itself, the proposed paradigm involves fixating a stable, non-fibrosing artificial capsule. Any standard or premium IOL can then be securely placed within this platform.

Universal Compatibility

A single Holder accommodates premium, toric, multifocal, and EDOF lenses. No need for specialized 3-piece clinical backup inventory.

Rotational Stability

Internal microscopic grooving prevents rotation of toric lenses, ensuring effective astigmatic correction over time.

Designed for Exchange

The platform does not undergo fibrosis. Lenses can be smoothly removed and exchanged decades later without damaging intraocular structures.

Clinical Indications & Surgical Anchoring

Scenario 1: Intact Anterior Capsulorhexis

When the anterior capsule is preserved, the Holder is directly anchored to the capsulorhexis margins via superior and inferior fixation grooves.

  • Minimal manipulation required.
  • Optimal physiological positioning.
Scenario 2: No Capsular Support

Scleral anchoring utilizing PMMA or Polypropylene supports (Valvecchia modification of Yamane technique) 2mm from the limbus.

  • 1 to 3 point triangular fixation.
  • Adjustable support length to prevent tilt and refine macular focus.
1

Standard 3.2 mm phacoemulsification incision.

2

Fixation of the Holder platform (Capsulorhexis or Scleral).

3

Implantation of preferred IOL into the artificial bag.

Surgical Placement Simulation

Global Device Positioning

3-Point Anchoring Detail

Structural Comparison Analysis

Clinical Feature Traditional Scleral Fixation (e.g., Yamane) HOLDER
What is Fixated IOL Haptics Artificial Capsular Platform
Adjustability Post-Fixation No Yes (Adjustable scleral supports)
Premium IOL Compatibility Limited (Monofocal 3-piece primarily) Universal (Toric, Multifocal, EDOF)
Future IOL Exchange Highly Difficult / Traumatic Designed for unobstructed exchange
Tilt Control Strategy Variable precision Triangular equidistant fixation design

Pediatric Cataract Management

Addressing refractive evolution in growing eyes.

Historically, pediatric IOL implantation before age 2 forced a choice between extreme short-term refractive targets or long-term ametropia relying on external correction to prevent amblyopia.

The modular nature of the Holder allows for sequential IOL exchanges. As the axial length of the child's globe elongates, the IOL power can be safely updated over the years without risking capsular trauma. This allows maintaining emmetropia throughout childhood development.

Development & Regulatory Status

  • Patent Registration: Approved by the Instituto Nacional de Propiedad Intelectual (INPI), Argentina.
  • Current Phase: Preclinical experimental testing in biological models.
  • Upcoming Milestones: Planned clinical research protocols with voluntary human subjects in collaboration with the FacoExtrema community and Xlabs.

Notice: This device is currently for investigational use and research only. Not yet approved for commercial distribution.

Future Platform Vision

Because the device maintains a stable, fibrotic-free intraocular volume, future research pathways are exploring its use as a housing for advanced modular tech.

This includes structured evaluation of intraocular electronic modules, biometry sensors, or meta-displays that require periodic extraction and upgrading over a patient's lifetime.

Professional Inquiries & Collaboration

Select your professional classification to route your inquiry to the appropriate clinical or research coordinator.

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