Epiretinal MembraneNCT03045367
Mid-term Evaluation of Metamorphopsia in Epiretinal Membrane Surgery
An observational study of Epiretinal Membrane and Cataract Senile, run by Clinica Oculistica dell'Università di Torino.
Trial summary
This study evaluates the safety and efficacy simultaneous, trans-conjunctival, 25-Gauge vitrectomy and phacoemulsification with intraocular lens implant in patients with metamorphopsia and visual impairment due to idiopathic epiretinal membrane and cataract. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Epiretinal Membrane, Cataract Senile
- What is being tested?
- Phacoemulsification, intraocular lens implant, vitrectomy.
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 22 Jun 2015to 31 Oct 2016
- How long will I take part?
- 180 Days
- Phase
- Observational
- 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 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatient of all gender, with complain of visual impairment and distortion
Who may be able to join
- age > 55 years
- visual acuity ≤ 20/40
- idiopathic epiretinal membrane
- cataract
- Amsler test positive for metamorphopsia.
Who cannot join
- previous ocular interventions
- other ocular diseases.
About this study
Official title: Mid-term Clinical Assessment and Correlation Between Metamorphopsia, Visual Acuity and Foveal Thickness in Idiopathic Epiretinal Membrane and Cataract Surgery
This study evaluates the safety and efficacy simultaneous, trans-conjunctival, 25-Gauge vitrectomy and phacoemulsification with intraocular lens implant in patients with metamorphopsia and visual impairment due to idiopathic epiretinal membrane and cataract. All 30 patients recruited underwent complete ocular examination, visual acuity measurement with ETDRS, metamorphopsia assessment with M-Charts and Metamorphometry® and foveal thickness evaluation by sd-OCT preoperatively, at 30, 90, 180 days postoperatively.
- Conditions
- Epiretinal Membrane, Cataract Senile
- Being tested
- Phacoemulsification, intraocular lens implant, vitrectomy.
- Keywords
- Metamorphopsia, Epiretinal membrane, Vitrectomy
- Medical subject headings
- Epiretinal Membrane, Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phacoemulsification, intraocular lens implant, vitrectomy.Procedure or surgery
Cataract extraction, intraocular lens implant, vitrectomy, epiretinal membrane and inner limiting retinal membrane peeling.
| Study group | Role | What they receive |
|---|---|---|
| Outpatients | Phacoemulsification, intraocular lens implant, vitrectomy. Receives: Procedure: Phacoemulsification, intraocular lens implant, vitrectomy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metamorphopsia
Change in spatial degree of distortion perception
Measured: Change in metamorphopsia from baseline at 180 days.
Visual Acuity
Change in LogMAR visual acuity
Measured: Change in visual acuity from baseline at 180 days
Area of central scotoma
Change in area, in square pixel, of central scotoma
Measured: Change in area of central scotoma from baseline at 180 days
Central fovea thickness
Change in fovea thickness in µm at the Sd OCT
Measured: Change in fovea thickness from baseline at 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2017 (estimated)
- Study start22 Jun 2015
- Primary completion31 Oct 2016
- Study completion31 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epiretinal MembraneStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
- Target duration
- 180 Days
Sponsor and investigators
- Lead sponsor
- Clinica Oculistica dell'Università di Torino
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco DAL VECCHIO, MD, Clinica Oculistica dell'Università di Torino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03045367
- Sponsor's protocol ID
- CS/526
- Status last verified
- Feb 2017
- First submitted
- 1 Feb 2017
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mid-term Clinical Assessment and Correlation Between Metamorphopsia, Visual Acuity and Foveal Thickness in Idiopathic Epiretinal Membrane and Cataract Surgery
- ClinicalTrials.gov ID
- NCT03045367
- Acronym / sponsor ID
- CS/526
- Conditions
- Epiretinal Membrane, Cataract Senile
- Keywords
- Metamorphopsia, Epiretinal membrane, Vitrectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Clinica Oculistica dell'Università di TorinoUniversity, hospital or other
- Study start
- 22 Jun 2015 (actual)
- Primary completion
- 31 Oct 2016 (actual)
- Study completion
- 31 Oct 2016 (actual)
- First posted
- 7 Feb 2017 (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.
This study evaluates the safety and efficacy simultaneous, trans-conjunctival, 25-Gauge vitrectomy and phacoemulsification with intraocular lens implant in patients with metamorphopsia and visual impairment due to idiopathic epiretinal membrane and cataract. All 30 patients recruited underwent complete ocular examination, visual acuity measurement with ETDRS, metamorphopsia assessment with M-Charts and Metamorphometry® and foveal thickness evaluation by sd-OCT preoperatively, at 30, 90, 180 days postoperatively.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 180 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Outpatients | – | Procedure: Phacoemulsification, intraocular lens implant, vitrectomy.Phacoemulsification, intraocular lens implant, vitrectomy. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatient of all gender, with complain of visual impairment and distortion
Key inclusion criteria (5 listed)
- age > 55 years
- visual acuity ≤ 20/40
- idiopathic epiretinal membrane
- cataract
- Amsler test positive for metamorphopsia.
Key exclusion criteria (2 listed)
- previous ocular interventions
- other ocular diseases.
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 |
|---|---|---|
| Phacoemulsification, intraocular lens implant, vitrectomy.Cataract extraction, intraocular lens implant, vitrectomy, epiretinal membrane and inner limiting retinal membrane peeling. | Procedure or surgery | Outpatients |
Primary outcome
Metamorphopsia
Time frame: Change in metamorphopsia from baseline at 180 days.
Change in spatial degree of distortion perception
Visual Acuity
Time frame: Change in visual acuity from baseline at 180 days
Change in LogMAR visual acuity
Area of central scotoma
Time frame: Change in area of central scotoma from baseline at 180 days
Change in area, in square pixel, of central scotoma
Central fovea thickness
Time frame: Change in fovea thickness from baseline at 180 days
Change in fovea thickness in µm at the Sd OCT
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 7 Feb 2017.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Epiretinal Membrane and Cataract Senile, run by Clinica Oculistica dell'Università di Torino.
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 5 inclusion and 2 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 7 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Metamorphopsia (time frame: Change in metamorphopsia from baseline at 180 days.). The study lists 4 primary outcomes in all. 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 7 Feb 2017.