Retinal SensitivityNCT03488576
Foveal Sparing of the ILM
A study testing Complete Macular Peeling and Macular Peeling with Foveal Sparing in people with Retinal Sensitivity, run by Università degli Studi di Brescia.
Trial summary
To compare the retinal sensitivity of complete internal limiting membrane (ILM) peeling versus foveal sparing ILM peeling during vitrectomy for epiretinal membrane or macular hole. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Retinal Sensitivity
- What is being tested?
- Complete Macular Peeling and Macular Peeling with Foveal Sparing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2014to 30 Jun 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- provision of written informed consent
- age > 60 years
- presence of idiopathic macular pucker or macular hole documented by OCT
Who cannot join
- any prior intraocular surgery
- pathologic myopia (> 7 diopters)
- age related macular degeneration
- glaucoma and diabetic retinopathy or any other retinal vascular disease
About this study
Official title: Macular Peeling With Foveal Sparing of the Internal Limiting Membrane: A Pilot Study
To compare the retinal sensitivity of complete internal limiting membrane (ILM) peeling versus foveal sparing ILM peeling during vitrectomy for epiretinal membrane or macular hole.
- Conditions
- Retinal Sensitivity
- Being tested
- Complete Macular Peeling, Macular Peeling with Foveal Sparing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complete Macular PeelingProcedure or surgery
A complete peeling of the internal limiting membrane was performed
Macular Peeling with Foveal SparingProcedure or surgery
A partial peeling of the internal limiting membrane was performed, sparing the fovea.
| Study group | Role | What they receive |
|---|---|---|
| Complete Peeling | Active comparator | Patient underwent scheduled vitrectomy for epiretinal membrane or macular hole with complete macular peeling of the internal limiting membrane. Receives: Procedure: Complete Macular Peeling |
| Foveal Sparing | Experimental | Patient underwent scheduled vitrectomy for epiretinal membrane or macular hole with partial peeling the internal limiting membrane (foveal sparing). Receives: Procedure: Macular Peeling with Foveal Sparing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal Sensitivity (dB)
Microperimetry was done to assess macular sensitivity
Measured: 12-month
Visual Acuity (LogMAR)
ETDRS charts were used to assess best corrected visual acuity
Measured: 12-month
Central Retinal Thickness (microns)
Optical Coherence Tomography will be used to assess central retinal thickness
Measured: 12-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start1 Jul 2014
- Primary completion31 Dec 2016
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal SensitivityStudies 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
- Parallel groups
- Model description
- This was a prospective study including ninety-one eyes of 190 phakic patients scheduled to undergo vitrectomy for idiopathic macular pucker or macular hole, from July 2014 to December 2016. Patients were randomized in a 1:1 ratio to complete peeling of the ILM (CP group) or foveal sparing (FS group).
- Masking
- None (open label)
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Brescia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Semeraro, Università degli Studi di Brescia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03488576
- Sponsor's protocol ID
- Vitreo003
- Status last verified
- Mar 2018
- First submitted
- 28 Mar 2018
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- 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 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Macular Peeling With Foveal Sparing of the Internal Limiting Membrane: A Pilot Study
- ClinicalTrials.gov ID
- NCT03488576
- Acronym / sponsor ID
- Vitreo003
- Conditions
- Retinal Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Università degli Studi di BresciaUniversity, hospital or other
- Study start
- 1 Jul 2014 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 5 Apr 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.
To compare the retinal sensitivity of complete internal limiting membrane (ILM) peeling versus foveal sparing ILM peeling during vitrectomy for epiretinal membrane or macular hole.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This was a prospective study including ninety-one eyes of 190 phakic patients scheduled to undergo vitrectomy for idiopathic macular pucker or macular hole, from July 2014 to December 2016. Patients were randomized in a 1:1 ratio to complete peeling of the ILM (CP group) or foveal sparing (FS group).
| Arm | Type | Receives |
|---|---|---|
| Complete Peeling | Active comparator | Procedure: Complete Macular PeelingPatient underwent scheduled vitrectomy for epiretinal membrane or macular hole with complete macular peeling of the internal limiting membrane. |
| Foveal Sparing | Experimental | Procedure: Macular Peeling with Foveal SparingPatient underwent scheduled vitrectomy for epiretinal membrane or macular hole with partial peeling the internal limiting membrane (foveal sparing). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- provision of written informed consent
- age > 60 years
- presence of idiopathic macular pucker or macular hole documented by OCT
Key exclusion criteria (4 listed)
- any prior intraocular surgery
- pathologic myopia (> 7 diopters)
- age related macular degeneration
- glaucoma and diabetic retinopathy or any other retinal vascular disease
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 |
|---|---|---|
| Complete Macular PeelingA complete peeling of the internal limiting membrane was performed | Procedure or surgery | Complete Peeling |
| Macular Peeling with Foveal SparingA partial peeling of the internal limiting membrane was performed, sparing the fovea. | Procedure or surgery | Foveal Sparing |
Primary outcome
Retinal Sensitivity (dB)
Time frame: 12-month
Microperimetry was done to assess macular sensitivity
Visual Acuity (LogMAR)
Time frame: 12-month
ETDRS charts were used to assess best corrected visual acuity
Central Retinal Thickness (microns)
Time frame: 12-month
Optical Coherence Tomography will be used to assess central retinal thickness
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 Apr 2018.
- Individual participant dataSharing planned: No
Related trials for Retinal Sensitivity
Recruiting
Light Bulb Stimuli to Reduce Chronic Pain
Fibromyalgia, Musculoskeletal Pain
Recruiting
Chromatic Retinal Stimulation to Reduce Chronic Pain and Pain Sensitivity
Chronic Low-back Pain, Chronic Pain
Not yet recruiting
RePer-AGE: Reorganization of Visuo-cognitive Functions Based on Peripheral Vision With Aging
Aging, Visual Perception
Active, not recruitingPhase 3
Oral N-acetylcysteine for Retinitis Pigmentosa
Retinitis Pigmentosa
Active, not recruitingObservational study
Natural History Study in Patients With PDE6A-, PDE6B- and RHO-linked Retinitis Pigmentosa
Retinitis Pigmentosa
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?
A study testing Complete Macular Peeling and Macular Peeling with Foveal Sparing in people with Retinal Sensitivity, run by Università degli Studi di Brescia.
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 4 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 Apr 2018. 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?
Retinal Sensitivity (dB) (time frame: 12-month). The study lists 3 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 5 Apr 2018.