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POST MARKET CLINICAL FOLLOW-UP STUDY OF THE HOYA NANEX TM PRELOADED MONOFOCAL INTRAOCULAR LENSES

Organizational Data

DRKS-ID:
DRKS00023382
Recruitment Status:
Recruiting complete, study complete
Date of registration in DRKS:
2021-01-15
Last update in DRKS:
2024-02-01
Registration type:
Prospective

Acronym/abbreviation of the study

NANX-103-VISN

URL of the study

No Entry

Brief summary in lay language

The purpose of this study is to confirm safety and performance of the Nanex™ multiSert+™ preloaded monofocal IOL system.

Brief summary in scientific language

The study objective is to evaluate the monocular visual acuities and the rates of adverse events in subjects implanted with the monofocal preloaded Nanex™ IOL (NY1-SP). All study endpoints will be evaluated.

Health condition or problem studied

ICD10:
H26.9 - Cataract, unspecified
Healthy volunteers:
No

Interventions, Observational Groups

Arm 1:
Collect and evaluate clinical data on safety and performance of actual registered and marketed HOYA Surgical Optics Nanex IOL within the duration of the study with 7 visits at different time points (preoperative, surgery, postop 1 day, postop 1 week, postop 30 days, postop 6 months, postop 12 months) Examinations: visual acuities, subjective refraction, keratometry, slit-lamp examination, topography, pupil sizes, adverse events/complaints and subjective questionnaire for surgeons and subjects.

Endpoints

Primary outcome:
- monocular best corrected distance visual acuity with reading chart - Incidence of adverse events All study endpoints will be evaluated at Form 4 (4-6-month postoperative) and Form 5 (11 to 14 months postoperative).
Secondary outcome:
- UDVA at Form 4 with reading chart - Percentage of eyes with SEQ within ± 0.50 D and ± 1.00 D versus target with reading chart

Study Design

Purpose:
Other
Allocation:
N/A (single arm study)
Control:
  • Uncontrolled/single arm
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
No
Assignment:
Single (group)
Sequence generation:
No Entry
Who is blinded:
No Entry

Recruitment

Recruitment Status:
Recruiting complete, study complete
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
  • Philippines
  • Poland
  • Spain
Number of study centers:
Multicenter study
Recruitment location(s):
  • Medical center Klinikum Stuttgart – Katharinenhospital (KH) Stuttgart
  • Medical center Augenklinik Ahaus Ahaus
  • Doctor's practice Walsrode
  • Medical center Augen- und Laserklinik Castrop-Rauxel GmbH Castrop-Rauxel
  • Medical center Bürgerhospital Frankfurt Frankfurt a.M.
  • Medical center Clínica OFTALVIST Jerez Jeréz, Spain
  • University medical center Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH Bochum
  • Medical center Zentrum für Refraktive Chirurgie, Augenzentrum am St. Franziskus Hospital Münster
  • Doctor's practice Düsseldorf
  • Medical center Klinik für Augenheilkunde und Poliklinik Homburg
  • Other Augenzentrum Prof. Dr. Koch GmbH Frankfurt am Main
  • Other Grupo OFTALVIST Madrid
  • Medical center Hospital Nuestra Señora de Gracia Zaragoza
  • Medical center Hospital Universitario Donostia San Sebastian
  • Medical center Przychodnia i Szpital Okulistyczny RETINA Warsaw
  • Medical center Peregine Eye and Laser Institute Makati City

Recruitment period and number of participants

Planned study start date:
2021-01-29
Actual study start date:
2021-01-27
Planned study completion date:
2023-12-31
Actual Study Completion Date:
2023-10-12
Target Sample Size:
192
Final Sample Size:
201

Inclusion Criteria

Sex:
All
Minimum Age:
22 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
Adult subjects with a minimum age of 22 years and planned for lens extraction (e.g. cataract, dysfunctional lens syndrome) and implantation of the study IOL and otherwise healthy eyes.

Exclusion Criteria

1. Various eye diseases that could reduce visual acuity. 2. Study participant is pregnant, or planning to become pregnant or breastfeeding. 3. Concurrent participation or participation within 30 days in another clinical trial.

Addresses

Primary Sponsor

HOYA Surgical Optics GmbH
De-Saint-Exupéry-Str. 10
60549 Frankfurt am Main
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
No

Contact for Scientific Queries

Hoya Surgical Optics, Inc.
Michael Bonilla
525 Technology Drive, Suite 280
92618 Irvine, CA
United States
Telephone:
001 (909) 286-9733
Fax:
No Entry
Contact per E-Mail
URL:
http://HOYA.com/SurgicalOptics

Contact for Public Queries

Hoya Surgical Optics, Inc.
Michael Bonilla
525 Technology Drive, Suite 280
92618 Irvine, CA
United States
Telephone:
001 (909) 286-9733
Fax:
No Entry
Contact per E-Mail
URL:
http://HOYA.com/SurgicalOptics

Principal Investigator

Hoya Surgical Optics, Inc.
Michael Bonilla
525 Technology Drive, Suite 280
92618 Irvine, CA
United States
Telephone:
001 (909) 286-9733
Fax:
No Entry
Contact per E-Mail
URL:
http://HOYA.com/SurgicalOptics

Sources of Monetary or Material Support

Commercial (pharmaceutical industry, medical engineering industry, etc.)

HOYA Surgical Optics GmbH
De-Saint-Exupéry-Str. 10
60549 Frankfurt am Main
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Ethik-Kommission der Landesärztekammer Hessen
Hanauer Landstraße 152
60314 Frankfurt am Main
Germany
Telephone:
+49-69-97672209
Fax:
+49-69-97672377
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2020-10-29
Ethics committee number:
2020-TEMP189286-evBO
Vote of the Ethics Committee:
Approved
Date of the vote:
2021-01-07

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
Post market clinical follow up Study

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry