Idiopathic Epiretinal Membrane, CataractNCT00376857
Surgical Removal of Idiopathic Epiretinal Membrane With and Without the Assistance of Indocyanine Green.
A study testing Surgery with and without the aid of Indocyanine Green (ICG) in people with Idiopathic Epiretinal Membrane, Cataract, run by University of Regensburg at 1 site in Germany.
Trial summary
It was the aim of the present study to prospectively compare the functional and morphological outcome of idiopathic epiretinal membrane surgery with and without the assistance of Indocyanine green (ICG). The main outcome measure was improvement of best-corrected visual acuity (BCVA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Epiretinal Membrane, Cataract
- What is being tested?
- Surgery with and without the aid of Indocyanine Green (ICG)
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Start not givento not given
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with IEM and cataract or posterior chamber intraocular lens pseudophakia complaining of loss of visual acuity and metamorphopsia during the past six months.
Who cannot join
- Other retinal disease, non-idiopathic epiretinal membrane, glaucoma or history of retinal detachment.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Dept. of Ophthalmology, University of Regensburg
Regensburg, 93042
About this study
Official title: Surgical Removal of Idiopathic Epiretinal Membrane With and Without the Assistance of Indocyanine Green: a Randomised Controlled Clinical Trial
It was the aim of the present study to prospectively compare the functional and morphological outcome of idiopathic epiretinal membrane surgery with and without the assistance of Indocyanine green (ICG). The main outcome measure was improvement of best-corrected visual acuity (BCVA). This was treated as an open question and we had no hypothesis which of the two therapies was superior.
- Conditions
- Idiopathic Epiretinal Membrane, Cataract
- Being tested
- Surgery with and without the aid of Indocyanine Green (ICG)
- Keywords
- Indocyanine green, toxicity, epiretinal membrane, visual field defect
- Medical subject headings
- Cataract, Epiretinal Membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery with and without the aid of Indocyanine Green (ICG)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
The main outcome measure was improvement of best-corrected visual acuity (BCVA).
Secondary outcomes (1)
Other outcome measures included postoperative BCVA, status of Amsler grid test, reduction of macular retinal thickness, residual or recurrent macular epiretinal membrane
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Epiretinal Membrane, CataractStudies 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
- Masking
- Single blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- University of Regensburg
- Sponsor type
- University, hospital or other
- Investigators
- Jost Hillenkamp, MD, Principal investigator, Dept. of Ophthalmology, University of RegensburgParykshit Saikia, MD, Principal investigator, Dept. of Ophthalmology, University of RegensburgHelmut G Sachs, MD, Study chair, Dept. of Ophthalmology, University of Regensburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00376857
- Sponsor's protocol ID
- 03123
- Status last verified
- Sep 2006
- First submitted
- 13 Sep 2006
- Last updated
- 15 Sep 2006
- Results posted
- No
Publications
Hillenkamp J, Saikia P, Herrmann WA, Framme C, Gabel VP, Sachs HG. Surgical removal of idiopathic epiretinal membrane with or without the assistance of indocyanine green: a randomised controlled clinical trial. Graefes Arch Clin Exp Ophthalmol. 2007 Jul;245(7):973-9. doi: 10.1007/s00417-006-0485-1. Epub 2006 Dec 21.
PubMed 17186261
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Removal of Idiopathic Epiretinal Membrane With and Without the Assistance of Indocyanine Green: a Randomised Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT00376857
- Acronym / sponsor ID
- 03123
- Conditions
- Idiopathic Epiretinal Membrane, Cataract
- Keywords
- Indocyanine green, toxicity, epiretinal membrane, visual field defect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- University of RegensburgUniversity, hospital or other
- First posted
- 15 Sep 2006 (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.
It was the aim of the present study to prospectively compare the functional and morphological outcome of idiopathic epiretinal membrane surgery with and without the assistance of Indocyanine green (ICG). The main outcome measure was improvement of best-corrected visual acuity (BCVA). This was treated as an open question and we had no hypothesis which of the two therapies was superior.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with IEM and cataract or posterior chamber intraocular lens pseudophakia complaining of loss of visual acuity and metamorphopsia during the past six months.
Key exclusion criteria (1 listed)
- Other retinal disease, non-idiopathic epiretinal membrane, glaucoma or history of retinal detachment.
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 |
|---|---|---|
| Surgery with and without the aid of Indocyanine Green (ICG) | Drug | – |
Primary outcome
The main outcome measure was improvement of best-corrected visual acuity (BCVA).
1 secondary outcome
Other outcome measures included postoperative BCVA, status of Amsler grid test, reduction of macular retinal thickness, residual or recurrent macular epiretinal membrane
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 15 Sep 2006.
- Derived from this study: PubMed 17186261Hillenkamp J, Saikia P, Herrmann WA, Framme C, Gabel VP, Sachs HG. Surgical removal of idiopathic epiretinal membrane with or without the assistance of indocyanine green: a randomised controlled clinical trial. Graefes Arch Clin Exp Ophthalmol. 2007 Jul;245(7):973-9. doi: 10.1007/s00417-006-0485-1. Epub 2006 Dec 21.
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.
Jost Hillenkamp, MD principal investigator
Dept. of Ophthalmology, University of Regensburg
Parykshit Saikia, MD principal investigator
Dept. of Ophthalmology, University of Regensburg
Helmut G Sachs, MD study chair
Dept. of Ophthalmology, University of Regensburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery with and without the aid of Indocyanine Green (ICG) in people with Idiopathic Epiretinal Membrane, Cataract, run by University of Regensburg at 1 site in Germany.
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 1 inclusion and 1 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 15 Sep 2006. 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 Germany. 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?
The main outcome measure was improvement of best-corrected visual acuity (BCVA).. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00376857, which also lists 1 linked publication.
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 15 Sep 2006; AzTrials last refreshed its copy on 8 Nov 2026.