PILOT CLINICAL INVESTIGATION OF THE EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS, MODEL 1R211R

PILOT CLINICAL INVESTIGATION OF THE EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS, MODEL 1R211R - 101.211R

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00003181

Enrollment

Registered

2011-08-02

Start date

2011-07-04

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

GRAUERSTAR h25

Interventions

Group 1: The patient will receive the study lens (model 1R211R) into one eye and the control lens (TECNIS® One-Piece monofocal IOL) into the other eye. This process is randomized. Group 2: Patient wil

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Healthy patients with bilateral cataract; women must not be pregnant or breast-feeding

Exclusion criteria

Exclusion criteria: uncontrolled systemic or oculare deseases; participation in another study

Design outcomes

Primary

Measure	Time frame
The visual acuity of patients will be determined in different distances one and three months after implantation of the IOLs. A questionnaire on the satisfaction of the patients will be filled in.	—

Secondary

Measure	Time frame
Advers events according ISO 14155 will be evaluated during the course of the study. During the postoperative examinations after 1 and 3 months, optical-visual symptoms, lens related and medical complications will be evaluated. A questionnaire for the subjective satisfaction of the patients will be performed.	—

Countries

Austria, Germany

Contacts

Public ContactRoland Pohl

AMO Vertreter für Europa

roland.pohl@amo.abbott07243-729451

Outcome results

None listed

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