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A Single Centre Study to Analyze Cataract Surgery Following Femtosecond Laser-Assisted and Manual Cataract Surgery

NCT01769313 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2014-10-31

No results posted yet for this study

Summary

This clinical study (non AMG/non MPG) is a contralateral, comparative, randomized, prospective, single-center, multi-surgeon, investigator masked study to investigate whether the femtolaser cataract surgery causes any significant differences in the resulting Intra Ocular Lens overlap (ΔROverlap) as compared to the conventional, manual continuous curvilinear capsulorhexis (CCC). The Intra Ocular Lens overlap (ΔROverlap) is defined as the difference between the Intra Ocular Lens center of mass to the capsulotomy aperture center of mass.

Conditions

  • Cataract

Interventions

DEVICE

Laser-assisted cataract surgery

The anterior capsulotomy and lens fragmentation will be performed by means of femtosecond laser surgery

DEVICE

Manually performed cataract surgery

The anterior capsulotomy and lens fragmentation will be performed manually.

Sponsors & Collaborators

  • Technolas Perfect Vision GmbH

    lead INDUSTRY

Principal Investigators

  • Gerd U Auffarth, Prof. Dr. · Universitäts-Augenklinik Heidelberg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01769313 on ClinicalTrials.gov