Age Related CataractsFLAMENCT03465124
Evaluation of Central Macular Thickness in Femtosecond Laser-assisted Cataract Surgery
A study testing Femtosecond Laser and Manual Cataract Surgery in people with Age Related Cataracts and Cystoid Macular Edema, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Age Related Cataracts, Cystoid Macular Edema
- What is being tested?
- Femtosecond Laser and Manual Cataract Surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteAustria
- Study dates
- 26 Mar 2018to 6 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Corneal abnormality
- Preceding ocular surgery or trauma
- Uncontrolled glaucoma
- Proliferative diabetic retinopathy
- Macular degeneration
- Iris neovascularization
Show all 11Show fewer
- History of uveitis/iritis
- Microphthalmus
- Recurrent intraocular inflammation of unknown etiology
- Blind fellow eye
- Uncontrolled systemic or ocular disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Central Macular Thickness in Femtosecond Laser-assisted Cataract Surgery - FLAME
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
- Being tested
- Femtosecond Laser, Manual Cataract Surgery
- Medical subject headings
- Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femtosecond LaserDevice
Femtosecond Laser assisted Cataract Surgery will be performed unilateral in randomized order. Contralateral eye will receive conventional cataract surgery
Manual Cataract SurgeryOther
conventional cataract surgery as control
| Study group | Role | What they receive |
|---|---|---|
| Femtosecond Laser assisted Cataract Surgery | Active comparator | Femtosecond Laser assisted Cataract Surgery will be performed unilateral in randomized order. Receives: Device: Femtosecond Laser |
| Manual Cataract Surgery | Active comparator | Manual Cataract Surgery will be performed in contralateral (to LCS) eye of patient with bilateral age-related cataract. Receives: Other: Manual Cataract Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central Macular Thickness
Difference in Central Macular Thickness (CMT) between Femtosecond Laser-assisted Cataract Surgery (LCS) to Manual Cataract Surgery (MCS)
Measured: Baseline to 6 weeks postoperative
Secondary outcomes (2)
Influence of lens density on quantitative autofluorescence
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.
Measured: Baseline to 1 weel, 3 weeks and 6 weeks postoperative
Central Macular Thickness
Difference in Central Macular Thickness (CMT) between Femtosecond Laser-assisted Cataract Surgery (LCS) to Manual Cataract Surgery (MCS)
Measured: Baseline to 1 week, 3 weeks, 6 weeks postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start26 Mar 2018
- Primary completion19 Feb 2019
- Study completion6 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Age Related CataractsStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rupert Menapace, Medical University of Vienna
- Investigators
- Rupert Menapace, MD, Principal investigator, Medical Universitiy of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03465124
- Sponsor's protocol ID
- 1053/2018
- Acronym
- FLAME
- Status last verified
- Mar 2019
- First submitted
- 1 Mar 2018
- Last updated
- 7 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34135449
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Central Macular Thickness in Femtosecond Laser-assisted Cataract Surgery - FLAME
- ClinicalTrials.gov ID
- NCT03465124
- Acronym / sponsor ID
- FLAME / 1053/2018
- Conditions
- Age Related Cataracts, Cystoid Macular Edema
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 26 Mar 2018 (actual)
- Primary completion
- 19 Feb 2019 (actual)
- Study completion
- 6 Apr 2019 (estimated)
- First posted
- 14 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Femtosecond Laser assisted Cataract Surgery | Active comparator | Device: Femtosecond LaserFemtosecond Laser assisted Cataract Surgery will be performed unilateral in randomized order. |
| Manual Cataract Surgery | Active comparator | Other: Manual Cataract SurgeryManual Cataract Surgery will be performed in contralateral (to LCS) eye of patient with bilateral age-related cataract. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (11 listed)
- Corneal abnormality
- Preceding ocular surgery or trauma
- Uncontrolled glaucoma
- Proliferative diabetic retinopathy
- Macular degeneration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Femtosecond LaserFemtosecond Laser assisted Cataract Surgery will be performed unilateral in randomized order. Contralateral eye will receive conventional cataract surgery | Device | Femtosecond Laser assisted Cataract Surgery |
| Manual Cataract Surgeryconventional cataract surgery as control | Other | Manual Cataract Surgery |
Primary outcome
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)
2 secondary outcomes
Influence of lens density on quantitative autofluorescence
Time frame: Baseline to 1 weel, 3 weeks and 6 weeks postoperative
Central Macular Thickness
Time frame: Baseline to 1 week, 3 weeks, 6 weeks postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2019.
- Derived from this study: PubMed 34135449Reiter 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rupert Menapace, MD principal investigator
Medical Universitiy of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Femtosecond Laser and Manual Cataract Surgery in people with Age Related Cataracts and Cystoid Macular Edema, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central Macular Thickness (time frame: Baseline to 6 weeks postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03465124, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2019; AzTrials last refreshed its copy on 8 Nov 2026.