Age Related CataractsNCT03390361
Release of Proinflammatory Cytokines (IL-1β, IL-6) and Total-prostaglandin (PG) Following Femtosecond Laser-assisted Cataract Surgery Compared to Manual Cataract Surgery
A study testing Femtosecond Laser-assisted and Manual Cataract Surgery in people with Age Related Cataracts, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Patients with bilateral age related cataract will be included in the study. Manual cataract surgery (MCS) will be performed in one eye and laser cataract surgery (LCS) in the corresponding eye. LCS will be performed with an approved femtosecond laser (FSL) device with an integrated imaging system. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Age Related Cataracts
- What is being tested?
- Femtosecond Laser-assisted and Manual Cataract Surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteAustria
- Study dates
- 5 Apr 2016to 25 Nov 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Bilateral age-related cataract necessitating phacoemulsification extraction and posterior intraocular lens implantation.
- Pupil dilation of ≥ 6.5mm
- Age 40 and older
Who cannot join
- Corneal abnormality
- Pseudoexfoliation
- Preceding ocular surgery or trauma
- Uncontrolled glaucoma
- Proliferative diabetic retinopathy
- Iris neovascularization
Show all 13Show fewer
- History of uveitis/iritis
- Microphthalmus
- Recurrent intraocular inflammation of unknown etiology
- Blind fellow eye
- Uncontrolled systemic or ocular disease
- Pregnancy
- Lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraindividual Comparison of Proinflammatory Cytokines (IL-1β, IL-6) and Total-prostaglandin (PG) Following Femtosecond Laser-assisted Cataract Surgery Using a Low-energy, High-frequency Femtosecond Laser-Device Compared to Manual Cataract Surgery
Patients with bilateral age related cataract will be included in the study. Manual cataract surgery (MCS) will be performed in one eye and laser cataract surgery (LCS) in the corresponding eye. LCS will be performed with an approved femtosecond laser (FSL) device with an integrated imaging system.
After surgery aqueous humour will be collected and screened with Enzyme-linked Immunosorbent Assay (ELISA) Kits for Interleukin-1β; Interleukin-6 and PG.
- Conditions
- Age Related Cataracts
- Being tested
- Femtosecond Laser-assisted, Manual Cataract Surgery
- Keywords
- Laser Cataract Surgery, Prostaglandin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femtosecond Laser-assistedDevice
Laser cataract surgery will be performed in one eye
Manual Cataract SurgeryProcedure or surgery
Manual cataract surgery will be performed in contralateral eye
| Study group | Role | What they receive |
|---|---|---|
| LCS | Active comparator | Laser cataract surgery will be performed. 5-minutes after LCS aqueous humour will be collected and frozen in -80° celsius. Receives: Device: Femtosecond Laser-assisted |
| MCS | Placebo comparator | Manual cataract surgery will be performed. Aqueous humour will be collected and frozen in -80° celsius before MCS starts. Receives: Procedure: Manual Cataract Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proinflammatory cytokines (IL-1β, IL-6) and total-PG
Interleukin IL-1β, Interleukin IL-6, total-prostaglandin
Measured: 5 minutes after laser procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2018
- Study start5 Apr 2016
- Primary completion9 Aug 2016
- Study completion25 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Patients' eyes will be randomized into two groups receiving either MCS or LCS. In the LCS group aqueous humour will be collected exactly five minutes after laser pretreatment. In the MCS group aqueous humour will be collected before manual manipulation of anterior chamber. Aqueous humour will be screened with Enzyme-linked Immunosorbent Assay (ELISA) Kits for Interleukin-1β; Interleukin-6 and PG.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 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 University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03390361
- Sponsor's protocol ID
- Femto IL + PG Study
- Status last verified
- Jan 2018
- First submitted
- 28 Dec 2017
- Last updated
- 5 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraindividual Comparison of Proinflammatory Cytokines (IL-1β, IL-6) and Total-prostaglandin (PG) Following Femtosecond Laser-assisted Cataract Surgery Using a Low-energy, High-frequency Femtosecond Laser-Device Compared to Manual Cataract Surgery
- ClinicalTrials.gov ID
- NCT03390361
- Acronym / sponsor ID
- Femto IL + PG Study
- Conditions
- Age Related Cataracts
- Keywords
- Laser Cataract Surgery, Prostaglandin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 5 Apr 2016 (actual)
- Primary completion
- 9 Aug 2016 (actual)
- Study completion
- 25 Nov 2016 (actual)
- First posted
- 4 Jan 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.
Patients with bilateral age related cataract will be included in the study. Manual cataract surgery (MCS) will be performed in one eye and laser cataract surgery (LCS) in the corresponding eye. LCS will be performed with an approved femtosecond laser (FSL) device with an integrated imaging system.
After surgery aqueous humour will be collected and screened with Enzyme-linked Immunosorbent Assay (ELISA) Kits for Interleukin-1β; Interleukin-6 and PG.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Patients' eyes will be randomized into two groups receiving either MCS or LCS. In the LCS group aqueous humour will be collected exactly five minutes after laser pretreatment. In the MCS group aqueous humour will be collected before manual manipulation of anterior chamber. Aqueous humour will be screened with Enzyme-linked Immunosorbent Assay (ELISA) Kits for Interleukin-1β; Interleukin-6 and PG.
| Arm | Type | Receives |
|---|---|---|
| LCS | Active comparator | Device: Femtosecond Laser-assistedLaser cataract surgery will be performed. 5-minutes after LCS aqueous humour will be collected and frozen in -80° celsius. |
| MCS | Placebo comparator | Procedure: Manual Cataract SurgeryManual cataract surgery will be performed. Aqueous humour will be collected and frozen in -80° celsius before MCS starts. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Bilateral age-related cataract necessitating phacoemulsification extraction and posterior intraocular lens implantation.
- Pupil dilation of ≥ 6.5mm
- Age 40 and older
Key exclusion criteria (13 listed)
- Corneal abnormality
- Pseudoexfoliation
- Preceding ocular surgery or trauma
- Uncontrolled glaucoma
- Proliferative diabetic retinopathy
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 Laser-assistedLaser cataract surgery will be performed in one eye | Device | LCS |
| Manual Cataract SurgeryManual cataract surgery will be performed in contralateral eye | Procedure or surgery | MCS |
Primary outcome
Proinflammatory cytokines (IL-1β, IL-6) and total-PG
Time frame: 5 minutes after laser procedure
Interleukin IL-1β, Interleukin IL-6, total-prostaglandin
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2018.
- 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 University 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-assisted and Manual Cataract Surgery in people with Age Related Cataracts, 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 3 inclusion and 13 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: finished, as of the sponsor's last update on 5 Jan 2018. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proinflammatory cytokines (IL-1β, IL-6) and total-PG (time frame: 5 minutes after laser procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jan 2018.