GlaucomaFEMTOHTONCT02835482
Effect of Elevated Intraocular Pressure in Glaucoma Patients During Femtolaser Cataract Surgery
A study testing Femtolaser surgery and Phacoemulsification in people with Glaucoma and Cataract, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
The use of the femtosecond laser causes an increase in the intraocular pressure (IOP) between 100 mm Hg and 200 mm Hg for a period of about 80 seconds (suction phase). If it is known that elevated IOP accelerates the degradation of retinal ganglion cells, whose axons form the optic nerve. Read more about this study
- Who is it for?
- Any age
- What is being tested?
- Femtolaser surgery and Phacoemulsification
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 14 Apr 2016to 16 Nov 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- scheduled bilateral cataract surgery
- bilateral known glaucoma confirmed at the preoperative consultation (glaucoma group) or absence of glaucoma in both eyes at confirmed the preoperative consultation (control group).
Who cannot join
- ophthalmologic pathology known other than glaucoma
- diabetes
- untreated hypertension
- multiple sclerosis
- Graves' disease
- sarcoidosis
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- patient taking toxic drug for the optic nerve and the retina
- neurodegenerative disease
- all general diseases that can affect the ocular structures
- eye surgery history
- patient's opposition to participation in the study, according to the law on research into routine care
- absence of affiliation to social security or to universal medical coverage
- legally protected patient
- pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
The use of the femtosecond laser causes an increase in the intraocular pressure (IOP) between 100 mm Hg and 200 mm Hg for a period of about 80 seconds (suction phase).
If it is known that elevated IOP accelerates the degradation of retinal ganglion cells, whose axons form the optic nerve.
Read more
No data has been published to date on potential adverse effects of femtolaser cataract surgery performed in patients with glaucomatous optic neuropathy.
Since some time, spectral-domain optical coherence tomography (SD -OCT) provides a detailed analysis of ganglion cell complex (GCC) for which the loss is a marker of glaucomatous optic neuropathy. The resolution of this device, about a few microns, can detect even a tiny loss of this layer.
The investigators propose to evaluate the effects of elevated intraocular pressure in glaucoma patients undergoing femtolaser cataract surgery, studying the GCC through SD-OCT.
- Being tested
- Femtolaser surgery, Phacoemulsification
- Medical subject headings
- Glaucoma, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femtolaser surgeryProcedure or surgery
PhacoemulsificationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Patient with glaucoma | Experimental | Patient eligible for bilateral cataract surgery, with glaucoma. Each patient is his own control. The patient is treated with femtolaser surgery for one eye and with phacoemulsification for the other eye. Receives: Procedure: Femtolaser surgery; Procedure: Phacoemulsification |
| Patient without glaucoma | Other | Patient eligible for bilateral cataract surgery, without glaucoma. Each patient is his own control. The patient is treated with femtolaser surgery for one eye and with the phacoemulsification for the other eye. Receives: Procedure: Femtolaser surgery; Procedure: Phacoemulsification |
What is being measured
The primary outcome is the main question the study is designed to answer.
In patient with glaucoma, measure of the thickness of the ganglion cell complex in the operated eye with femtosecond laser versus the operated eye with phacoemulsification.
Measured: within the first 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2016 (estimated)
- Study start14 Apr 2016
- Primary completion16 Nov 2017
- Study completion16 Nov 2017
Why it stopped: Difficulties encountered with patients inclusion and femtolaser availability
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe 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
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02835482
- Sponsor's protocol ID
- AGC_2014-19
- Acronym
- FEMTOHTO
- Status last verified
- Dec 2017
- First submitted
- 11 Jul 2016
- Last updated
- 21 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Elevated Intraocular Pressure in Glaucoma Patients During Femtolaser Cataract Surgery
- ClinicalTrials.gov ID
- NCT02835482
- Acronym / sponsor ID
- FEMTOHTO / AGC_2014-19
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties encountered with patients inclusion and femtolaser availability
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 14 Apr 2016 (actual)
- Primary completion
- 16 Nov 2017 (actual)
- Study completion
- 16 Nov 2017 (actual)
- First posted
- 18 Jul 2016 (estimated)
- 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 use of the femtosecond laser causes an increase in the intraocular pressure (IOP) between 100 mm Hg and 200 mm Hg for a period of about 80 seconds (suction phase).
If it is known that elevated IOP accelerates the degradation of retinal ganglion cells, whose axons form the optic nerve.
No data has been published to date on potential adverse effects of femtolaser cataract surgery performed in patients with glaucomatous optic neuropathy.
Since some time, spectral-domain optical coherence tomography (SD -OCT) provides a detailed analysis of ganglion cell complex (GCC) for which the loss is a marker of glaucomatous optic neuropathy. The resolution of this device, about a few microns, can detect even a tiny loss of this layer.
The investigators propose to evaluate the effects of elevated intraocular pressure in glaucoma patients undergoing femtolaser cataract surgery, studying the GCC through SD-OCT.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient with glaucoma | Experimental | Procedure: Femtolaser surgery, Procedure: PhacoemulsificationPatient eligible for bilateral cataract surgery, with glaucoma. Each patient is his own control. The patient is treated with femtolaser surgery for one eye and with phacoemulsification for the other eye. |
| Patient without glaucoma | Other | Procedure: Femtolaser surgery, Procedure: PhacoemulsificationPatient eligible for bilateral cataract surgery, without glaucoma. Each patient is his own control. The patient is treated with femtolaser surgery for one eye and with the phacoemulsification for the other eye. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- scheduled bilateral cataract surgery
- bilateral known glaucoma confirmed at the preoperative consultation (glaucoma group) or absence of glaucoma in both eyes at confirmed the preoperative consultation (control group).
Key exclusion criteria (14 listed)
- ophthalmologic pathology known other than glaucoma
- diabetes
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 |
|---|---|---|
| Femtolaser surgery | Procedure or surgery | Patient with glaucoma, Patient without glaucoma |
| Phacoemulsification | Procedure or surgery | Patient with glaucoma, Patient without glaucoma |
Primary outcome
In patient with glaucoma, measure of the thickness of the ganglion cell complex in the operated eye with femtosecond laser versus the operated eye with phacoemulsification.
Time frame: within the first 3 months after surgery
Results and safety
The study was stopped early (reason given: Difficulties encountered with patients inclusion and femtolaser availability). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Femtolaser surgery and Phacoemulsification in people with Glaucoma and Cataract, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
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 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: stopped early, as of the sponsor's last update on 21 Dec 2017. 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 France. 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?
The study was stopped early (reason given: Difficulties encountered with patients inclusion and femtolaser availability). 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?
In patient with glaucoma, measure of the thickness of the ganglion cell complex in the operated eye with femtosecond laser versus the operated eye with phacoemulsification. (time frame: within the first 3 months after surgery). 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 21 Dec 2017.