CataractNCT06578884
A Prospective Clinical Investigation to Evaluate the Safety and Performance of 877PTY Toric IOL for Visual Correction of Corneal Astigmatism
An observational study of Cataract and Corneal Astigmatism, run by Medicontur Medical Engineering Ltd at 1 site in Hungary.
Trial summary
Medicontur preloaded hydrophobic monofocal toric intraocular lenses (IOLs) are indicated to improve vision at far distance in adults with or without cataract and correction of pre-existing corneal astigmatism secondarily to removal of the crystalline lens. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract, Corneal Astigmatism
- What is being tested?
- 877PTY
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteHungary
- Study dates
- 16 Apr 2024to 30 Jun 2025
- Phase
- Observational
- 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
Study population: Aphakic adult patients (18 years old and older), with cataract and corneal astigmatism who aspire to have improved uncorrected distance vision and reduction of the residual refractive cylinder and assigned to monocular or binocular implantation with 877PTY IOL.
Who may be able to join
- adult patients (18 years old and older);
- cataract and/or corneal astigmatism diagnosis;
- indication for cataract surgery or refractive lens exchange;
- recommended cylinder correction with toric IOL with cylinder power ≥1.0D;
- clear intraocular media other than cataract;
- signed informed consent form;
Who cannot join
- irregular astigmatism;
- patients who are not targeted to emmetropia (predicted residual spherical equivalent and/or astigmatism is out of the range of ±0.5D and ±0.38D respectively);
- any retinopathy or maculopathy that affects the vision;
- iris neovascularization;
- congenital eye abnormality affecting visual performance;
- advanced glaucoma;
Show all 24Show fewer
- pseudoexfoliation syndrome affecting IOL stability;
- amblyopia;
- uveitis;
- retinal detachment;
- prior ocular surgery in personal medical history;
- irregular corneal curvature or corneal diseases affecting visual performance;
- high myopia (axial length ≥ 26,5 mm);
- inadequate visualization of the fundus on preoperative examination;
- dilated pupil size not large enough to visualize toric IOL axis markings postoperatively based on the Investigator's decision;
- eye trauma in medical history;
- instability of keratometry or biometry measurements;
- prior corneal refractive surgery such as LASIK, PRK, or SMILE;
- patients deemed ineligible by the investigator because of any systemic disease or treatment;
- pregnancy or lactation;
- current use of systemic steroids or external ophthalmic drugs;
- concurrent participation in another drug or device investigation.
- Intraoperative exclusions: the presence of the following intraoperative exclusion criteria will lead to the exclusion of the subject:
- Any unexpected or serious intraoperative complication that makes IOL implantation impossible or results in implantation of another type of IOL that is outside the scope of this clinical trial.
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Győr-Moson-Sopron Vármegyei Petz Aladár Egyetemi Oktató Kórház
Győr, 9024
About this study
Medicontur preloaded hydrophobic monofocal toric intraocular lenses (IOLs) are indicated to improve vision at far distance in adults with or without cataract and correction of pre-existing corneal astigmatism secondarily to removal of the crystalline lens.
The intraocular lens is intended to be surgically implanted into the eye with the purpose of restoring optical function in the aphakic eye to provide an optical system with high predictability of the precalculated dioptric power.
Read more
The investigation will be performed as a prospective, non-comparative, single arm study with a single center design. Patients will be enrolled who are assigned to be implanted with the 877PTY IOLs mono- or binocularly between January 2024 - June 2025.
Data from six visits will be collected:
- Visit 1: Screening and Baseline (up to 90 days prior to the surgery)
- Visit 2: IOL implantation (Day 0)
- Visit 3: Day 1 post-operatively (+/- 0 day)
- Visit 4: Day 7 post-operatively (+/- 3 days)
- Visit 5: Month 1 post-operatively (+/- 2 weeks)
- Visit 6: Month 6 post-operatively (+/- 1 month)
- Conditions
- Cataract, Corneal Astigmatism
- Being tested
- 877PTY
- Keywords
- cataract, intraocular lens (IOL), astigmatism correction, aphakic
- Medical subject headings
- Cataract, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
877PTYDevice
IOL implantation with 6-month follow-up period Monocular UDVA/CDVA Manifest Refraction (SPH, CYL, SEQ) Optical Biometry, Keratometry (K1, K2, AXL, ACD) IOL axis orientation determination Visual function questionnaire Glistening evaluation Tonometry Slit-Lamp examination Fundus visualization
| Study group | Role | What they receive |
|---|---|---|
| 877PTY | 100 patients/eyes implanted with 877PTY IOL Receives: Device: 877PTY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Performance Endpoint - CDVA
Visual acuity: monocular CDVA at 6 months after IOL implantation
Measured: 6 months postoperatively
Secondary outcomes (7)
Secondary Performance Endpoint - UDVA
Visual acuity: monocular UDVA at 6 months after IOL implantation
Measured: 6 months postoperatively
Secondary Performance Endpoint - Subjective CYL
Subjective (manifest) cylinder and keratometric cylinder of the eye at 6 months postoperatively
Measured: 6 months postoperatively
Secondary Performance Endpoint - Residual CYL and SEQ
Residual manifest cylinder and spherical equivalent at 6 months postoperatively;
Measured: 6 months postoperatively
Secondary Performance Endpoint - Rotational stability
IOL rotational stability at 6 months after IOL implantation;
Measured: 6 months postoperatively
Secondary Performance Endpoint - Injector handling
Ease of IOL implantation and positioning at surgery;
Measured: 6 months postoperatively
Secondary Performance Endpoint - Patient satisfaction (VFQ-25)
Patient-reported visual functions: overall global vision rating, difficulty with near and distance vision activities, social functioning and role limitations, dependency on others, mental health symptoms due to vision, driving difficulties, limitations with peripheral and color vision, and ocular pain evaluated by visual function questionnaire at 6 months after IOL implantation.
Measured: 6 months postoperatively
Secondary Performance Endpoint - Glistening
Glistening rate and severity at 6 months after IOL implantation
Measured: 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start16 Apr 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medicontur Medical Engineering Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06578884
- Sponsor's protocol ID
- M-877PTY-HU-2301
- Status last verified
- Aug 2024
- First submitted
- 10 Jun 2024
- Last updated
- 30 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Investigation to Evaluate the Safety and Performance of 877PTY Toric IOL for Visual Correction of Corneal Astigmatism
- ClinicalTrials.gov ID
- NCT06578884
- Acronym / sponsor ID
- M-877PTY-HU-2301
- Conditions
- Cataract, Corneal Astigmatism
- Keywords
- cataract, intraocular lens (IOL), astigmatism correction, aphakic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medicontur Medical Engineering LtdIndustry (pharma, biotech, devices)
- Study start
- 16 Apr 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 30 Aug 2024 (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.
Medicontur preloaded hydrophobic monofocal toric intraocular lenses (IOLs) are indicated to improve vision at far distance in adults with or without cataract and correction of pre-existing corneal astigmatism secondarily to removal of the crystalline lens.
The intraocular lens is intended to be surgically implanted into the eye with the purpose of restoring optical function in the aphakic eye to provide an optical system with high predictability of the precalculated dioptric power.
The investigation will be performed as a prospective, non-comparative, single arm study with a single center design. Patients will be enrolled who are assigned to be implanted with the 877PTY IOLs mono- or binocularly between January 2024 - June 2025.
Data from six visits will be collected:
- Visit 1: Screening and Baseline (up to 90 days prior to the surgery)
- Visit 2: IOL implantation (Day 0)
- Visit 3: Day 1 post-operatively (+/- 0 day)
- Visit 4: Day 7 post-operatively (+/- 3 days)
- Visit 5: Month 1 post-operatively (+/- 2 weeks)
- Visit 6: Month 6 post-operatively (+/- 1 month)
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 877PTY | – | Device: 877PTY100 patients/eyes implanted with 877PTY IOL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Aphakic adult patients (18 years old and older), with cataract and corneal astigmatism who aspire to have improved uncorrected distance vision and reduction of the residual refractive cylinder and assigned to monocular or binocular implantation with 877PTY IOL.
Key inclusion criteria (6 listed)
- adult patients (18 years old and older);
- cataract and/or corneal astigmatism diagnosis;
- indication for cataract surgery or refractive lens exchange;
- recommended cylinder correction with toric IOL with cylinder power ≥1.0D;
- clear intraocular media other than cataract;
Key exclusion criteria (24 listed)
- irregular astigmatism;
- patients who are not targeted to emmetropia (predicted residual spherical equivalent and/or astigmatism is out of the range of ±0.5D and ±0.38D respectively);
- any retinopathy or maculopathy that affects the vision;
- iris neovascularization;
- congenital eye abnormality affecting visual performance;
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 |
|---|---|---|
| 877PTYIOL implantation with 6-month follow-up period Monocular UDVA/CDVA Manifest Refraction (SPH, CYL, SEQ) Optical Biometry, Keratometry (K1, K2, AXL, ACD) IOL axis orientation determination Visual function questionnaire Glistening evaluation Tonometry Slit-Lamp examination Fundus visualization | Device | 877PTY |
Primary outcome
Primary Performance Endpoint - CDVA
Time frame: 6 months postoperatively
Visual acuity: monocular CDVA at 6 months after IOL implantation
7 secondary outcomes
Secondary Performance Endpoint - UDVA
Time frame: 6 months postoperatively
Secondary Performance Endpoint - Subjective CYL
Time frame: 6 months postoperatively
Secondary Performance Endpoint - Residual CYL and SEQ
Time frame: 6 months postoperatively
Secondary Performance Endpoint - Rotational stability
Time frame: 6 months postoperatively
Secondary Performance Endpoint - Injector handling
Time frame: 6 months postoperatively
Secondary Performance Endpoint - Patient satisfaction (VFQ-25)
Time frame: 6 months postoperatively
Secondary Performance Endpoint - Glistening
Time frame: 6 months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract and Corneal Astigmatism, run by Medicontur Medical Engineering Ltd at 1 site in Hungary.
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 6 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. 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?
Results are not available in the source record.
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?
Primary Performance Endpoint - CDVA (time frame: 6 months postoperatively). 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 30 Aug 2024.