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Clinical Trials/DRKS00015270
DRKS00015270
Completed
Phase 2

A PROSPECTIVE CONTROLLED CLINICAL STUDY TO EVALUATE THE SAFETY AND PERORMANCE OF THE HOYA SURGICAL OPTICS VIVINEX®GEMETRIC™ PRE-LOADED INTRAOCULAR LENS - GEMT-101-DEEP

Hoya Medical Singapore PTE. LTD.0 sites509 target enrollmentOctober 17, 2018
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Conditionsh25Senile cataract

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
h25
Sponsor
Hoya Medical Singapore PTE. LTD.
Enrollment
509
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 17, 2018
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
Hoya Medical Singapore PTE. LTD.

Eligibility Criteria

Inclusion Criteria

  • •1\.Adult subjects with a minimum age of 22 years
  • •2\.Planned for mono\- or bilateral lens extraction (e.g. cataract, dysfunctional lens syndrome) and implantation of the investigational IOL
  • •3\.Planned for bilateral lens extraction (e.g. cataract, dysfunctional lens syndrome) and implantation of the control IOL
  • •4\.Clear intraocular media other than cataract
  • •5\.Expected postoperative corrected distance visual acuity of 0,1 logMAR (0,8 decimal) or better in the study eye/s
  • •6\.Subjects who require a spherical equivalent lens power from \+13\.0 D to 27,5 D in the study eye/s
  • •7\.Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visits
  • •8\.Ability to read and to consent to participation in study
  • •9\.Signed informed consent

Exclusion Criteria

  • •1\.Patients who need a legal representative or cannot read or understand the ICF
  • •2\.Endothelial cell count \< 2000 cells/mm2
  • •3\.Intraocular inflammation or recurrent ocular inflammatory condition
  • •4\.Previous intraocular and corneal surgery (e.g. LASIK, LASEK, RK, PRK, etc.), including corneal refractive surgery, or retinal surgery on the study eyes
  • •5\.Lentodonesis or other capsular bag pathologies (e.g. after traumatic cataract) in the study eye/s
  • •6\.Instability of keratometry or biometry measurements
  • •7\.Strabismus, amblyopia or single eye status
  • •8\.Pupil abnormalities (e.g. non\-reactive, fixed pupils, or abnormally shaped pupils)
  • •9\.Irregular astigmatism
  • •10\.More than 1\.0 D of expected postoperative corneal astigmatism

Outcomes

Primary Outcomes

Not specified

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