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Clinical Follow-Up Study Evaluating glistening of IOLs in Routine Practice

Clinical Follow-Up Study Evaluating glistening of IOLs in Routine Practice - GLIS

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00012764
Enrollment
100
Registered
2017-11-30
Start date
2017-07-31
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

h25

Interventions

Group 1: The study design is retrospective and controlled. The study will be done at a single center. Patient will be examined at only a single visit. Up to 100 subjects already implanted with a HOYA

Sponsors

Hoya Surgical Optics
Lead Sponsor

Eligibility

Sex/Gender
All
Age
22 Years to No maximum

Inclusion criteria

Inclusion criteria: • Patients implanted with IOL • Minimum 22 years of age • Available and comply to study procedures • Ability and willingness to sign informed consent

Exclusion criteria

Exclusion criteria: • Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes • Concurrent participation or participation within 30 days prior to preoperative visit in any other clinical trial with an investigational product

Design outcomes

Primary

MeasureTime frame
Distance corrected visual acuity measured at single postoperative visit, using visual acuity charts at a minimum of 4 meter

Secondary

MeasureTime frame
1. Device related adverse events (ADEs and SADEs) 2. Subjective grading of glistening 3. Optical/ visual symptoms

Countries

Germany

Contacts

Public ContactGerd Auffahrt

Universitäts-Augenklinik

Raquel.WillrichAmroussi@med.uni-heidelberg.de+49-6221-56-6624

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026