---
title: Clinical Study to Investigate Visual Performance of a Hydrophobic Monofocal IOL After Bilateral Implantation
nct_id: NCT03423524
overall_status: COMPLETED
phase: NA
sponsor: Beaver-Visitec International, Inc.
study_type: INTERVENTIONAL
primary_condition: Cataract
countries: Belgium
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03423524.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03423524"
ct_last_update_post_date: 2022-02-15
last_seen_at: "2026-05-12T06:11:44.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Clinical Study to Investigate Visual Performance of a Hydrophobic Monofocal IOL After Bilateral Implantation

**NCT ID:** [NCT03423524](https://clinicaltrials.gov/study/NCT03423524)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 20
- **Lead Sponsor:** Beaver-Visitec International, Inc.
- **Conditions:** Cataract, Lens Opacities
- **Start Date:** 2018-05-02
- **Completion Date:** 2021-07-27
- **CT.gov Last Update:** 2022-02-15

## Brief Summary

Prospective, non-randomised, open, controlled, single-center post-market clinical follow study about Micropure 1.2.3 IOL.

## Detailed Description

This clinical investigation is a prospective, non-randomised, open, controlled, single-center post-market clinical follow whereby study patients undergoing routine cataract surgery will have bilateral implantation of monofocal intraocular lenses Micropure 1.2.3. (PhysIOL, Liège, Belgium)

The study purpose is to obtain clinical data on visual acuity and contrast sensitivity on patients implanted with Micropure 1.2.3.

The device under investigation (Micropure 1.2.3.) is a monofocal glistening-free hydrophobic acrylic intraocular lens (IOL) manufactured by the sponsor of this study PhysIOL sa/nv. The IOL will be implanted as part of the routine cataract surgery on patients suffering from cataract development.

In total 50 patients will be recruited for this clinical study and receive a bilateral implantation of Micropure 1.2.3. intraocular lens.

Subjects participating in the trial will attend a total of 8 study visits (1 preoperative, 2 operative and 5 postoperative) over a period of 2 Years.

## Eligibility

- **Minimum age:** 45 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* Cataractous eyes with no comorbidity
* Availability, willingness and sufficient cognitive awareness to comply with examination procedures
* Signed informed consent

Exclusion Criteria:

* Irregular astigmatism
* Age of patient \< 45 years
* Regular corneal astigmatism \>0.75 dioptres by an automatic keratometer or biometer or \>1.0 dioptres if the steep axis of cylinder is between 90° and 120°
* Difficulty for cooperation (distance from their home, general health condition)
* Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc…)
* Any ocular comorbidity
* History of ocular trauma or prior ocular surgery including refractive procedures
* Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic Uveitis, Marfan's syndrome)
* Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions)
* Complicated surgery
* Patients who do not give informed consent
```

## Arms

- **Arm: Investigational Device** (EXPERIMENTAL) — Implantation of monofocal intraocular lens (IOL) "Micropure 1.2.3." consisting of hydrophobic material

## Interventions

- **Micropure 1.2.3.** (DEVICE) — Implantation of intraocular lens (IOL). Name: "MicroPure 1.2.3." It is a monofocal intraocular lens consisting of hydrophobic acrylic material. One IOL per eye will be implanted

## Primary Outcomes

- **monocular Corrected Distance Visual Acuity (CDVA)** _(time frame: 3 months postoperative)_ — Statistically non-inferior visual acuity outcomes on monocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions compared to literature data on a monofocal hydrophilic IOL (Bausch \& Lomb - Akreos MI60) at the 3 months follow up visit.

## Secondary Outcomes

- **Manifested refraction** _(time frame: 1 month, 3 months, 12 months, 24 months postoperative)_
- **Monocular and binocular Uncorrected Distance Visual Acuity (UDVA)** _(time frame: 1 month, 3 months, 12 months, 24 months postoperative)_
- **Monocular and binocular Uncorrected Intermediate Visual Acuity (UIVA)** _(time frame: 1 month, 3 months, 12 months, 24 months postoperative)_
- **Monocular and binocular Distance Corrected Intermediate Visual Acuity (DCIVA)** _(time frame: 1 month, 3 months, 12 months, 24 months postoperative)_
- **Binocular Corrected Distance Visual Acuity (CDVA)** _(time frame: 1 month, 3 months, 12 months, 24 months postoperative)_
- **Monocular and binocular Contrast Sensitivity under photopic and mesopic light conditions** _(time frame: 1 month, 3 months, 12 months, 24 months postoperative)_
- **Monocular and binocular assessment of defocus curve under photopic light conditions** _(time frame: 1 month, 3 months, 12 months, 24 months postoperative)_
- **Slitlamp examination - Corneal status** _(time frame: 12 months, 24 months postoperative)_
- **Slitlamp examination - Fundus** _(time frame: 12 months, 24 months postoperative)_
- **Slitlamp examination - Signs of inflammation** _(time frame: 12 months, 24 months postoperative)_
- **Slitlamp examination - Pupillary block** _(time frame: 12 months, 24 months postoperative)_
- **Slitlamp examination - Retinal detachment** _(time frame: 12 months, 24 months postoperative)_
- **Slitlamp examination - Status of anterior and posterior capsule** _(time frame: 12 months, 24 months postoperative)_
- **Slitlamp examination - IOL decentration** _(time frame: 12 months, 24 months postoperative)_
- **Slitlamp examination IOL tilt** _(time frame: 12 months, 24 months postoperative)_
- **Slitlamp examination - IOL discoloration** _(time frame: 12 months, 24 months postoperative)_
- **Slitlamp examination - IOL opacity** _(time frame: 12 months, 24 months postoperative)_

## Locations (1)

- Ophtalmology department - CHU liège, Liège, Belgium

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.ophtalmology department - chu liège|liège||belgium` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT03423524*  
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