Evaluation of Central Macular Thickness in Femtosecond Laser-assisted Cataract Surgery
NCT ID: NCT03465124
Last Updated: 2019-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2018-03-26
2019-04-06
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
QUADRUPLE
Study Groups
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Femtosecond Laser assisted Cataract Surgery
Femtosecond Laser assisted Cataract Surgery will be performed unilateral in randomized order.
Femtosecond Laser
Femtosecond Laser assisted Cataract Surgery will be performed unilateral in randomized order. Contralateral eye will receive conventional cataract surgery
Manual Cataract Surgery
Manual Cataract Surgery will be performed in contralateral (to LCS) eye of patient with bilateral age-related cataract.
Manual Cataract Surgery
conventional cataract surgery as control
Interventions
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Femtosecond Laser
Femtosecond Laser assisted Cataract Surgery will be performed unilateral in randomized order. Contralateral eye will receive conventional cataract surgery
Manual Cataract Surgery
conventional cataract surgery as control
Eligibility Criteria
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Inclusion Criteria
* Age 40 and older (females of childbearing age will be interviewed if pregnancy is possible)
Exclusion Criteria
* Preceding ocular surgery or trauma
* Uncontrolled glaucoma
* Proliferative diabetic retinopathy
* Macular degeneration
* Iris neovascularization
* History of uveitis/iritis
* Microphthalmus
* Recurrent intraocular inflammation of unknown etiology
* Blind fellow eye
* Uncontrolled systemic or ocular disease
40 Years
ALL
No
Sponsors
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Medical University of Vienna
OTHER
Responsible Party
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Rupert Menapace
Principal Investigator
Principal Investigators
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Rupert Menapace, MD
Role: PRINCIPAL_INVESTIGATOR
Medical Universitiy of Vienna
Locations
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Medical University of Vienna
Vienna, , Austria
Countries
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References
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Reiter GS, Schwarzenbacher L, Schartmuller D, Roggla V, Leydolt C, Menapace R, Schmidt-Erfurth U, Sacu S. Influence of lens opacities and cataract severity on quantitative fundus autofluorescence as a secondary outcome of a randomized clinical trial. Sci Rep. 2021 Jun 16;11(1):12685. doi: 10.1038/s41598-021-92309-6.
Other Identifiers
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1053/2018
Identifier Type: -
Identifier Source: org_study_id
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