Age Related CataractsFemto-PGNCT03390400
Changes in Prostaglandin Levels in Laser Cataract Surgery (LCS) Subject to Laser Prevalence
A study testing Femtosecondlaser-assisted, Anterior Capsulotomy and Lens Fragmentation in people with Age Related Cataracts, run by Rupert Menapace 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 to 90 years
- Conditions the study is for
- Age Related Cataracts
- What is being tested?
- Femtosecondlaser-assisted, Anterior Capsulotomy and Lens Fragmentation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteAustria
- Study dates
- 29 May 2017to 14 Mar 2018
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Bilateral age-related cataract necessitating phacoemulsification extraction and posterior intraocular lens implantation
- Age: 40 to 90 (females of childbearing age will be interviewed if pregnancy is possible)
- Preoperative pupil dilation in mydriasis ≥ 6.5 mm
Who cannot join
- Preceding ocular surgery or trauma
- Recurrent intraocular inflammation of unknown etiology
- Uncontrolled glaucoma
- Uncontrolled systemic or ocular disease
- Blind fellow eye
- Microphthalmus
Show all 14Show fewer
- Corneal abnormality
- History of uveitis/iritis
- Iris neovascularization
- Pseudoexfoliation
- Proliferative diabetic retinopathy
- Pregnancy
- Lactation
- Females of childbearing age: not included
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraindividual Comparison of Prostaglandin E2 (PGE2) and Total-prostaglandin (PG) Following Femtosecond Laser-assisted Cataract Surgery Using a Low-energy, High-frequency Femtosecond Laser-Device in Regard to the Sequence of Anterior Capsulotomy and Lens Fragmentation
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. Aqueous humor will be collected and screening will be performed for Total Prostaglandin and Prostaglandin E2 via en-bloc Enzyme-linked Immunosorbent Assay (ELISA)-Kit.
- Conditions
- Age Related Cataracts
- Being tested
- Femtosecondlaser-assisted, Anterior Capsulotomy, Lens Fragmentation
- Keywords
- Laser Cataract Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femtosecondlaser-assistedDevice
Also called Laser assisted Cataract Surgery
Femtosecondlaser-assisted Cataract Surgery will be performed bilateral on the same day with different laser settings.
Anterior CapsulotomyProcedure or surgery
Cataract Surgery
Lens FragmentationProcedure or surgery
Cataract Surgery
| Study group | Role | What they receive |
|---|---|---|
| Anterior Capsulotomy before Lens Fragmentation | Active comparator | Anterior capsulotomy will be performed by femtosecond laser before lens fragmentation Receives: Device: Femtosecondlaser-assisted; Procedure: Anterior Capsulotomy |
| Lens Fragmentation before Anterior Capsulotomy | Active comparator | Lens fragmentation will be performed by femtosecond laser before anterior capsulotomy Receives: Device: Femtosecondlaser-assisted; Procedure: Lens Fragmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total-Prostaglandin and PGE2 level in aqueous humor
pg/mL
Measured: 5 minutes after laser procedure (LCS)
Secondary outcomes (1)
Change in Pupilsize
in mm
Measured: baseline, immediately after laser, 5 min after laser
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 start29 May 2017
- Primary completion2 Jan 2018
- Study completion14 Mar 2018 (estimated)
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.
- 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
- Bilateral femtosecond-laser assisted cataract surgery will be performed in individuals with age-related cataract. Eyes will be randomized into two groups receiving either anterior capsulotomy before lens fragmentation or vice versa in the contralateral eye. After laser procedure samples of aqueous humor will be collected and when complete all samples will be analysed by ELISA for Prostaglandin.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rupert Menapace
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rupert Menapace, Medical University of Vienna
- Investigators
- Rupert Menapace, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03390400
- Sponsor's protocol ID
- Femto-PGII Study
- Acronym
- Femto-PG
- Status last verified
- Mar 2018
- First submitted
- 28 Dec 2017
- Last updated
- 2 Mar 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 2 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraindividual Comparison of Prostaglandin E2 (PGE2) and Total-prostaglandin (PG) Following Femtosecond Laser-assisted Cataract Surgery Using a Low-energy, High-frequency Femtosecond Laser-Device in Regard to the Sequence of Anterior Capsulotomy and Lens Fragmentation
- ClinicalTrials.gov ID
- NCT03390400
- Acronym / sponsor ID
- Femto-PG / Femto-PGII Study
- Conditions
- Age Related Cataracts
- Keywords
- Laser Cataract Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Rupert MenapaceUniversity, hospital or other
- Study start
- 29 May 2017 (actual)
- Primary completion
- 2 Jan 2018 (actual)
- Study completion
- 14 Mar 2018 (estimated)
- 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.
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. Aqueous humor will be collected and screening will be performed for Total Prostaglandin and Prostaglandin E2 via en-bloc Enzyme-linked Immunosorbent Assay (ELISA)-Kit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Bilateral femtosecond-laser assisted cataract surgery will be performed in individuals with age-related cataract. Eyes will be randomized into two groups receiving either anterior capsulotomy before lens fragmentation or vice versa in the contralateral eye. After laser procedure samples of aqueous humor will be collected and when complete all samples will be analysed by ELISA for Prostaglandin.
| Arm | Type | Receives |
|---|---|---|
| Anterior Capsulotomy before Lens Fragmentation | Active comparator | Device: Femtosecondlaser-assisted, Procedure: Anterior CapsulotomyAnterior capsulotomy will be performed by femtosecond laser before lens fragmentation |
| Lens Fragmentation before Anterior Capsulotomy | Active comparator | Device: Femtosecondlaser-assisted, Procedure: Lens FragmentationLens fragmentation will be performed by femtosecond laser before anterior capsulotomy |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Bilateral age-related cataract necessitating phacoemulsification extraction and posterior intraocular lens implantation
- Age: 40 to 90 (females of childbearing age will be interviewed if pregnancy is possible)
- Preoperative pupil dilation in mydriasis ≥ 6.5 mm
Key exclusion criteria (14 listed)
- Preceding ocular surgery or trauma
- Recurrent intraocular inflammation of unknown etiology
- Uncontrolled glaucoma
- Uncontrolled systemic or ocular disease
- Blind fellow eye
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 |
|---|---|---|
| Femtosecondlaser-assistedAlso: Laser assisted Cataract SurgeryFemtosecondlaser-assisted Cataract Surgery will be performed bilateral on the same day with different laser settings. | Device | Anterior Capsulotomy before Lens Fragmentation, Lens Fragmentation before Anterior Capsulotomy |
| Anterior CapsulotomyCataract Surgery | Procedure or surgery | Anterior Capsulotomy before Lens Fragmentation |
| Lens FragmentationCataract Surgery | Procedure or surgery | Lens Fragmentation before Anterior Capsulotomy |
Primary outcome
Total-Prostaglandin and PGE2 level in aqueous humor
Time frame: 5 minutes after laser procedure (LCS)
pg/mL
1 secondary outcome
Change in Pupilsize
Time frame: baseline, immediately after laser, 5 min after laser
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 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 Femtosecondlaser-assisted, Anterior Capsulotomy and Lens Fragmentation in people with Age Related Cataracts, run by Rupert Menapace 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 14 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 2 Mar 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. 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?
Total-Prostaglandin and PGE2 level in aqueous humor (time frame: 5 minutes after laser procedure (LCS)). 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 2 Mar 2018.