Epiretinal MembraneEPIREFNCT02413619
Refractive Consequences of Epiretinal Membrane Surgery
A study testing Vitrectomy, Cataract surgery and Combined surgery in people with Epiretinal Membrane, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
Trial summary
Epiretinal membrane is treated with vitrectomy and peeling. Afterwards cataract is usually developed, which requires a cataract surgery. The aim of this study is to investigate the refractive consequences of surgery for Epiretinal membrane and cataract. Read more about this study
- Who is it for?
- Ages 50 to 99 years
- Conditions the study is for
- Epiretinal Membrane
- What is being tested?
- Vitrectomy, Cataract surgery and Combined surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteDenmark
- Study dates
- May 2014to Oct 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 50 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of Epiretinal membrane,
- visual complaints consistent with Epiretinal membrane,
- age more than 50 years,
- refraction less than ± 5 diopters and astigmatism less than 3 diopters,
- indication for vitrectomy is only Epiretinal membrane.
Who cannot join
- Previous intraocular surgery or laser-refractive procedure.
- Use of intraocular gas tamponade during the vitrectomy.
- Intraoperative manipulation of the intraocular lens.
- Serious complications (endophthalmitis, vitreous haemorrhage or retinal detachment).
- History of previous head or ocular trauma.
- Sulcus fixation of intraocular lens
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Eye Department Glostrup Hospital
Glostrup Municipality, DK, 2600
About this study
Epiretinal membrane is treated with vitrectomy and peeling. Afterwards cataract is usually developed, which requires a cataract surgery.
The aim of this study is to investigate the refractive consequences of surgery for Epiretinal membrane and cataract.
Investigators investigate the sequence of surgery in patients having surgery for Epiretinal membrane and cataract in a prospective clinically randomized intervention trial. Patients are randomized to 1) start with vitrectomy, 2) start with cataract surgery, 3) combined surgery. Investigators want to find the sequence of surgery that gives the most optimal refractive result, the most stabile intraocular lens, and the minimal loss of corneal endothelial cells.
Read the detailed description
Aim: To evaluate the impact of the sequence of surgery on the Refractive Error and the Corneal Endothelial Count in phakic individuals undergoing surgery for Epiretinal membrane.
Study design: Prospective interventional randomized clinical trial. Primary outcome: Refractive error (i.e. Intraocular lens power prediction error), Corneal Endothelial Count, and postoperative macular oedema.
Secondary outcome: Changes in axial length, anterior chamber depth and keratometry; the accuracy of formulas used to calculate the power of the intraocular lens.
Study population:
Identification of participants: Individuals referred to the Macular Surgery Clinic, Surgical Retina Team, Department of Ophthalmology, Glostrup University Hospital, Copenhagen, Denmark. The individuals should be signed up for surgery because of Epiretinal membrane at the clinic.
Method:
Individuals are randomized to the possible sequences of surgery (i.e. start with cataract surgery, start with vitrectomy, or combined surgery). Based on an estimated clinical relevant refractive prediction error of 0,50 diopter and a standard deviation of 0,50 diopter, a number of 20 individuals in each of the three groups are needed to obtain a power of 80 % and a type 1 error of 5 %. Total number of individuals is thus 60.
Clinical examinations are performed preoperatively and 2 weeks after each surgery (cataract surgery, vitrectomy or combined surgery), and 3 and 12 months postoperatively. The examinations include best corrected distance visual acuity, autorefraction/keratometry (Retinomax®, Nikon, Tokyo, Japan), subjective refraction, slit-lamp examination, fundoscopy and tonometry. Biometry by IOLMaster (Carl Zeiss, Meditec AG, Germany), intraocular power calculation with the SRK/T formula. Pentacam Scheimpflug Cornea tomography (Topcon, Tokyo, Japan). Corneal Endothelial Count obtained by three images of the central region of the corneal endothelium (Topcon SP-3000P, Tokyo, Japan). Heidelberg Optical Coherence Tomography, (Heidelberg Engineering, Heidelberg, Germany).
Sequence of surgery depends on randomization. In all cases a standard phacoemulsification (scleral tunnel or clear corneal incision) with in-the-bag intraocular lens implantation. In combined surgery, the cataract surgery is performed before vitrectomy during the same session. Vitreoretinal procedures include a standard three-port 23 gauge pars plana vitrectomy, membrane peeling, and the use of dyes. Cataract surgery is performed by one of two experienced surgeons, and vitrectomy is carried out by one experienced surgeon.
Analysis: A computer database will be created as a fill-in form to record all patient data, and a masked statistical analysis of all outcome measures will be performed. Statistical analysis will be performed to determine differences in baseline data among the three groups (age, sex, visual acuity, keratometry, axial length, anterior chamber depth, Corneal Endothelial Count). To identify independent predictors for all outcome measures at different follow-up times, multivariate regression analysis is performed. All calculations will be performed using SAS software.
- Conditions
- Epiretinal Membrane
- Being tested
- Vitrectomy, Cataract surgery, Combined surgery
- Medical subject headings
- Epiretinal Membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VitrectomyProcedure or surgery
Vitrectomy
Cataract surgeryProcedure or surgery
Cataract surgery
Combined surgeryProcedure or surgery
Combined vitrectomy and cataract surgery at the same time
| Study group | Role | What they receive |
|---|---|---|
| Start cataract | Active comparator | Patients start having cataract surgery. After one month they undergo vitrectomy Receives: Procedure: Cataract surgery |
| start vitrectomy | Active comparator | Patients start having vitrectomy. After one month they undergo cataract surgery. Receives: Procedure: Vitrectomy |
| combined surgery | Active comparator | Combined cataract surgery and vitrectomy at the same time Receives: Procedure: Combined surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Refractive Error
Prediction error of intraocular lens calculation (measured in diopters)
Measured: One year
Corneal endothelial count
measured in number of cells per square millimeter (mm2)
Measured: One year
Macula anatomy
Macula-anatomy success of surgery, i.e. the postoperative decrease of macula thickness or postoperative macular oedema. Measured in millimeter.
Measured: One year
Secondary outcomes (2)
Anterior Chamber Depth
measured in millimeter (mm)
Measured: One year
Axial length
measured in millimeter (mm)
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2015 (estimated)
- Study startMay 2014
- Primary completionOct 2016
- Study completionOct 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hassan Hamoudi, Glostrup University Hospital, Copenhagen
- Investigators
- Hassan Hamoudi, MD, Principal investigator, Eye Department Glostrup Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02413619
- Sponsor's protocol ID
- EPIREF
- Acronym
- EPIREF
- Status last verified
- Nov 2016
- First submitted
- 27 Mar 2015
- Last updated
- 10 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refractive Consequences of Epiretinal Membrane Surgery
- ClinicalTrials.gov ID
- NCT02413619
- Acronym / sponsor ID
- EPIREF / EPIREF
- Conditions
- Epiretinal Membrane
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 10 Apr 2015 (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.
Epiretinal membrane is treated with vitrectomy and peeling. Afterwards cataract is usually developed, which requires a cataract surgery.
The aim of this study is to investigate the refractive consequences of surgery for Epiretinal membrane and cataract.
Investigators investigate the sequence of surgery in patients having surgery for Epiretinal membrane and cataract in a prospective clinically randomized intervention trial. Patients are randomized to 1) start with vitrectomy, 2) start with cataract surgery, 3) combined surgery. Investigators want to find the sequence of surgery that gives the most optimal refractive result, the most stabile intraocular lens, and the minimal loss of corneal endothelial cells.
Detailed description
Aim: To evaluate the impact of the sequence of surgery on the Refractive Error and the Corneal Endothelial Count in phakic individuals undergoing surgery for Epiretinal membrane.
Study design: Prospective interventional randomized clinical trial. Primary outcome: Refractive error (i.e. Intraocular lens power prediction error), Corneal Endothelial Count, and postoperative macular oedema.
Secondary outcome: Changes in axial length, anterior chamber depth and keratometry; the accuracy of formulas used to calculate the power of the intraocular lens.
Study population:
Identification of participants: Individuals referred to the Macular Surgery Clinic, Surgical Retina Team, Department of Ophthalmology, Glostrup University Hospital, Copenhagen, Denmark. The individuals should be signed up for surgery because of Epiretinal membrane at the clinic.
Method:
Individuals are randomized to the possible sequences of surgery (i.e. start with cataract surgery, start with vitrectomy, or combined surgery). Based on an estimated clinical relevant refractive prediction error of 0,50 diopter and a standard deviation of 0,50 diopter, a number of 20 individuals in each of the three groups are needed to obtain a power of 80 % and a type 1 error of 5 %. Total number of individuals is thus 60.
Clinical examinations are performed preoperatively and 2 weeks after each surgery (cataract surgery, vitrectomy or combined surgery), and 3 and 12 months postoperatively. The examinations include best corrected distance visual acuity, autorefraction/keratometry (Retinomax®, Nikon, Tokyo, Japan), subjective refraction, slit-lamp examination, fundoscopy and tonometry. Biometry by IOLMaster (Carl Zeiss, Meditec AG, Germany), intraocular power calculation with the SRK/T formula. Pentacam Scheimpflug Cornea tomography (Topcon, Tokyo, Japan). Corneal Endothelial Count obtained by three images of the central region of the corneal endothelium (Topcon SP-3000P, Tokyo, Japan). Heidelberg Optical Coherence Tomography, (Heidelberg Engineering, Heidelberg, Germany).
Sequence of surgery depends on randomization. In all cases a standard phacoemulsification (scleral tunnel or clear corneal incision) with in-the-bag intraocular lens implantation. In combined surgery, the cataract surgery is performed before vitrectomy during the same session. Vitreoretinal procedures include a standard three-port 23 gauge pars plana vitrectomy, membrane peeling, and the use of dyes. Cataract surgery is performed by one of two experienced surgeons, and vitrectomy is carried out by one experienced surgeon.
Analysis: A computer database will be created as a fill-in form to record all patient data, and a masked statistical analysis of all outcome measures will be performed. Statistical analysis will be performed to determine differences in baseline data among the three groups (age, sex, visual acuity, keratometry, axial length, anterior chamber depth, Corneal Endothelial Count). To identify independent predictors for all outcome measures at different follow-up times, multivariate regression analysis is performed. All calculations will be performed using SAS software.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Start cataract | Active comparator | Procedure: Cataract surgeryPatients start having cataract surgery. After one month they undergo vitrectomy |
| start vitrectomy | Active comparator | Procedure: VitrectomyPatients start having vitrectomy. After one month they undergo cataract surgery. |
| combined surgery | Active comparator | Procedure: Combined surgeryCombined cataract surgery and vitrectomy at the same time |
Who may qualify
- Ages
- 50 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A diagnosis of Epiretinal membrane,
- visual complaints consistent with Epiretinal membrane,
- age more than 50 years,
- refraction less than ± 5 diopters and astigmatism less than 3 diopters,
- indication for vitrectomy is only Epiretinal membrane.
Key exclusion criteria (6 listed)
- Previous intraocular surgery or laser-refractive procedure.
- Use of intraocular gas tamponade during the vitrectomy.
- Intraoperative manipulation of the intraocular lens.
- Serious complications (endophthalmitis, vitreous haemorrhage or retinal detachment).
- History of previous head or ocular trauma.
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 |
|---|---|---|
| VitrectomyVitrectomy | Procedure or surgery | start vitrectomy |
| Cataract surgeryCataract surgery | Procedure or surgery | Start cataract |
| Combined surgeryCombined vitrectomy and cataract surgery at the same time | Procedure or surgery | combined surgery |
Primary outcome
Refractive Error
Time frame: One year
Prediction error of intraocular lens calculation (measured in diopters)
Corneal endothelial count
Time frame: One year
measured in number of cells per square millimeter (mm2)
Macula anatomy
Time frame: One year
Macula-anatomy success of surgery, i.e. the postoperative decrease of macula thickness or postoperative macular oedema. Measured in millimeter.
2 secondary outcomes
Anterior Chamber Depth
Time frame: One year
Axial length
Time frame: One year
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 10 Nov 2016.
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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.
Hassan Hamoudi, MD principal investigator
Eye Department Glostrup Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitrectomy, Cataract surgery and Combined surgery in people with Epiretinal Membrane, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
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 6 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 10 Nov 2016. 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 Denmark. 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 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?
Refractive Error (time frame: One year). 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 10 Nov 2016.