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

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ClinicalTrials.gov Identifier: NCT03465124
Recruitment Status : Active, not recruiting
First Posted : March 14, 2018
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
Rupert Menapace, Medical University of Vienna

Brief 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.


Condition or disease Intervention/treatment Phase
Age Related Cataracts Cystoid Macular Edema Device: Femtosecond Laser Other: Manual Cataract Surgery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Bilateral cataract surgery will be performed in individuals with age-related cataract. Eyes will be randomized into two groups receiving either Femtosecond Laser assisted Cataract Surgery (LCS) or conventional Manual Cataract Surgery (MCS).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Groups will be randomized. Randomization information will be put in a sealed envelope on screening date and opened in operating theatre right before procedure start.
Primary Purpose: Diagnostic
Official Title: Evaluation of Central Macular Thickness in Femtosecond Laser-assisted Cataract Surgery - FLAME
Actual Study Start Date : March 26, 2018
Actual Primary Completion Date : February 19, 2019
Estimated Study Completion Date : April 6, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Active Comparator: Femtosecond Laser assisted Cataract Surgery
Femtosecond Laser assisted Cataract Surgery will be performed unilateral in randomized order.
Device: Femtosecond Laser
Femtosecond Laser assisted Cataract Surgery will be performed unilateral in randomized order. Contralateral eye will receive conventional cataract surgery

Active Comparator: Manual Cataract Surgery
Manual Cataract Surgery will be performed in contralateral (to LCS) eye of patient with bilateral age-related cataract.
Other: Manual Cataract Surgery
conventional cataract surgery as control




Primary Outcome Measures :
  1. Central Macular Thickness [ Time Frame: Baseline to 6 weeks postoperative ]
    Difference in Central Macular Thickness (CMT) between Femtosecond Laser-assisted Cataract Surgery (LCS) to Manual Cataract Surgery (MCS)


Secondary Outcome Measures :
  1. Influence of lens density on quantitative autofluorescence [ Time Frame: Baseline to 1 weel, 3 weeks and 6 weeks postoperative ]

    Influence of lens density on quantitative autofluorescence will be assessed in qAF units. Images will be recorded after volume scans for each eye on designated visits.

    Quantitative Autofluorescence quantifies natural fundus autofluorescence with a Spectralis HRA+OCT. This method uses the same wavelength and confocal scanning laser ophthalmoscope as fundus autofluorescence (488nm; maximum power: 280 µW) and can be used to determine the integrity and vitality of the retinal pigment epithelium which is important for nourishment the retina.


  2. Central Macular Thickness [ Time Frame: Baseline to 1 week, 3 weeks, 6 weeks postoperative ]
    Difference in Central Macular Thickness (CMT) between Femtosecond Laser-assisted Cataract Surgery (LCS) to Manual Cataract Surgery (MCS)



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Bilateral Age-related cataract necessitating lens extraction and posterior IOL implantation
  • Age 40 and older (females of childbearing age will be interviewed if pregnancy is possible)

Exclusion Criteria:

  • Corneal abnormality
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03465124


Locations
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Austria
Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
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Principal Investigator: Rupert Menapace, MD Medical Universitiy of Vienna

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Responsible Party: Rupert Menapace, Principal Investigator, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT03465124     History of Changes
Other Study ID Numbers: 1053/2018
First Posted: March 14, 2018    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cataract
Macular Edema
Lens Diseases
Eye Diseases
Macular Degeneration
Retinal Degeneration
Retinal Diseases