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Evaluation of Central Macular Thickness in Femtosecond Laser-assisted Cataract Surgery

NCT03465124 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-03-07

No results posted yet for this study

Summary

The investigational device is an approved femtosecond laser (FSL) device with an integrated imaging system to perform certain steps of the cataract procedure. The FSL will perform anterior capsulotomy and lens fragmentation in individuals suffering from age-related cataract with need of cataract surgery.

Cataract surgery will be performed in subjects who have signed an informed consent form. Macula thickness will be measured with Spectralis OCT on screening date.

Postoperative examinations will be implemented in accordance with the approved investigational plan on subjects and includes: visual acuity, slitlamp examination, retinal oct imaging and quantitative autofluorescence.

Conditions

  • Age Related Cataracts
  • Cystoid Macular Edema

Interventions

DEVICE

Femtosecond Laser

Femtosecond Laser assisted Cataract Surgery will be performed unilateral in randomized order. Contralateral eye will receive conventional cataract surgery

OTHER

Manual Cataract Surgery

conventional cataract surgery as control

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Rupert Menapace, MD · Medical Universitiy of Vienna

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-26
Primary Completion
2019-02-19
Completion
2019-04-06

Countries

  • Austria

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 NCT03465124 on ClinicalTrials.gov