Idiopathic Macular HoleNCT00302328

Trial of Prognostic Factors and Surgical Methods for the Treatment of Idiopathic Macular Holes

A study testing macular hole operation in people with Idiopathic Macular Hole, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any age
Conditions the study is for: Idiopathic Macular Hole
What is being tested?: macular hole operation
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 78 participants
Where: 1 siteDenmark
Study dates: Aug 2005to Jan 2009
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Idiopathic macular hele stage 2 or 3.
Duration of Symptoms ≤ 12 months.
Visual acuity ≥ 34 ETDRS letters.
Intraocular pressure ≤ 23 mmHg.
Informed consent.

Who cannot join

Previous macular hole in project eye
Macular pucker worse than a cellophane macular reflex.
Previous surgery or disease in the eye affecting retinal function.
Systemic disease affection vision including diabetes mellitus with level of retinopathy ≥ 14a.
Amblyopia i project eye.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

Department of Ophthalmology, Glostrup Hospital
Copenhagen, DK-2600

Other trials in Denmark

About this study

Official title: A Randomised Clinical Trial of Prognostic Factors and Surgical Methods for the Treatment of Idiopathic Macular Holes

The project is a randomized clinical trial with a follow up time of 12 months comparing the effects of surgical treatment of idiopathic macular holes. Patients are randomized to vitrectomy alone, vitrectomy plus indocyanine green (ICG) assisted inner limiting membrane ( ILM) peeling or vitrectomy plus trypan blue (tb) assisted ILM peeling. At baseline patients are characterized using early treatment diabetic retinopathy study (ETDRS) visual charts, tests of aniseikonia, optical coherence tomography 3 (OCT3), visual field and fundus photography. Per- and postoperative complications are registered.

Data analyses will help clarify the effect of ILM peeling on hole closure and visual acuity. Comparing results after ICG- and tb assisted ILM peeling will help clarify the topic of a toxic effect on retinal cells after staining and peeling of the ILM. Changes in intraretinal morphology before and after dye-assisted ILM peeling will be studied using OCT3 imaging and the patients' subjective opinion on the surgical results will be analyzed using quality of life questionnaires and metamorphopsia tests.

Conditions: Idiopathic Macular Hole
Being tested: macular hole operation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

macular hole operationProcedure or surgery
macular hole surgery with either no peeling, indocyanine green (ICG) assisted peeling or trypan blue (tb) peeling

Study groups in NCT00302328
Study group	Role	What they receive
macular hole operation no peeling	No intervention	Not described
Macular hole operation ICG peeling	Active comparator	Not described Receives: Procedure: macular hole operation
Macular hole operation TB peeling	Experimental	Not described Receives: Procedure: macular hole operation

What is being measured

The primary outcome is the main question the study is designed to answer.

Visual Acuity (ETDRS Letters)
Visual acuity measured as the number of ETDRS letters at last follow-up
Measured: Visual acuity at 12 months

Secondary outcomes (2)

Anatomic Success
closure of the macular hole evaluated on optical coherence tomography 3 (OCT3)
Measured: macular hole closure at 12 months
Visual Field Defects
visual field defects measured on humphrey perimetry
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2005Jan 2009

First posted14 Mar 2006 (estimated)
Study startAug 2005
Primary completionJan 2008
Study completionJan 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Idiopathic Macular HoleStudies 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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 78 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00302328
Sponsor's protocol ID: COMAH
Status last verified: Mar 2014
First submitted: 13 Mar 2006
Last updated: 16 Apr 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Christensen UC. Value of internal limiting membrane peeling in surgery for idiopathic macular hole and the correlation between function and retinal morphology. Acta Ophthalmol. 2009 Dec;87 Thesis 2:1-23. doi: 10.1111/j.1755-3768.2009.01777.x.
PubMed 19912135
Christensen UC, Kroyer K, Sander B, Jorgensen TM, Larsen M, la Cour M. Macular morphology and visual acuity after macular hole surgery with or without internal limiting membrane peeling. Br J Ophthalmol. 2010 Jan;94(1):41-7. doi: 10.1136/bjo.2009.159582. Epub 2009 Aug 18.
PubMed 19692379
Kroyer K, Christensen U, la Cour M, Larsen M. Metamorphopsia assessment before and after vitrectomy for macular hole. Invest Ophthalmol Vis Sci. 2009 Dec;50(12):5511-5. doi: 10.1167/iovs.09-3530. Epub 2009 Jul 2.
PubMed 19578018
Christensen UC, Kroyer K, Sander B, Larsen M, Henning V, Villumsen J, la Cour M. Value of internal limiting membrane peeling in surgery for idiopathic macular hole stage 2 and 3: a randomised clinical trial. Br J Ophthalmol. 2009 Aug;93(8):1005-15. doi: 10.1136/bjo.2008.151266. Epub 2008 Nov 21.
PubMed 19028741
Kroyer K, Christensen U, Larsen M, la Cour M. Quantification of metamorphopsia in patients with macular hole. Invest Ophthalmol Vis Sci. 2008 Sep;49(9):3741-6. doi: 10.1167/iovs.07-1452. Epub 2008 Apr 30.
PubMed 18450594

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Comparative Study of Decellularized Human Amniotic Membrane Hydrogel and Inverted Internal Limiting Membrane Flap in Idiopathic Large Macular Holes
Macular Holes
Recruiting
Comparison Between Outcomes of Closure of Idiopathic Macular Hole Using Autologus Tenon Capsule Graft and Internal Limiting Membrane Flap Techniques (Pilot Study)
Macular Hole Surgery, ILM Peeling
Enrolling by invitation
Intraocular Gas Tamponade for Treatment of Large Idiopathic Macular Holes
Idiopathic Macular Hole, Macular Hole
Enrolling by invitation
Minimal Vitrectomy and ILM Flap with Sodium Hyaluronate Gel for MH
Macular Hole, Macular Hole Surgery
Recruiting
PEELED INTERNAL LIMITING MEMBRANE REPOSITION
Macular Holes

All Idiopathic Macular Hole trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised Clinical Trial of Prognostic Factors and Surgical Methods for the Treatment of Idiopathic Macular Holes
ClinicalTrials.gov ID: NCT00302328
Acronym / sponsor ID: COMAH
Conditions: Idiopathic Macular Hole
Study type: Interventional
Recruitment status: Completed
Enrolment: 78 participants (actual)
Lead sponsor: Glostrup University Hospital, CopenhagenUniversity, hospital or other
Collaborators: Danish Eye Health Society, The Danish Medical Research Council
Study start: Aug 2005
Primary completion: Jan 2008 (actual)
Study completion: Jan 2009 (actual)
First posted: 14 Mar 2006 (estimated)
Results: Posted 16 Apr 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
macular hole operation no peeling	No intervention	–
Macular hole operation ICG peeling	Active comparator	Procedure: macular hole operation
Macular hole operation TB peeling	Experimental	Procedure: macular hole operation

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

Idiopathic macular hele stage 2 or 3.
Duration of Symptoms ≤ 12 months.
Visual acuity ≥ 34 ETDRS letters.
Intraocular pressure ≤ 23 mmHg.
Informed consent.

Key exclusion criteria (5 listed)

Previous macular hole in project eye
Macular pucker worse than a cellophane macular reflex.
Previous surgery or disease in the eye affecting retinal function.
Systemic disease affection vision including diabetes mellitus with level of retinopathy ≥ 14a.
Amblyopia i project eye.

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
macular hole operationmacular hole surgery with either no peeling, indocyanine green (ICG) assisted peeling or trypan blue (tb) peeling	Procedure or surgery	Macular hole operation ICG peeling, Macular hole operation TB peeling

Primary outcome

Visual Acuity (ETDRS Letters)
Time frame: Visual acuity at 12 months
Visual acuity measured as the number of ETDRS letters at last follow-up

2 secondary outcomes

Anatomic Success
Time frame: macular hole closure at 12 months
Visual Field Defects
Time frame: 6 months

Results and safety

Results posted to the registry on 16 Apr 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
no Peeling	25	25
ICG Peeling	35	34
tb Peeling	18	18

Primary outcome: Visual Acuity (ETDRS Letters)

Time frame: Visual acuity at 12 months. Mean (Standard Error). Unit: Visual acuity in letters

Measure	no Peeling n = 25	ICG Peeling n = 34	tb Peeling n = 18
Value	74.9 (8.2)	72.4 (6.5)	72.2 (9.1)

Population analysed: Decided from initial power calculation

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
no Peeling	14 of 25 (56%)	0 of 25 (0%)	Not reported
ICG Peeling	3 of 35 (8.6%)	0 of 35 (0%)	Not reported
tb Peeling	2 of 18 (11.1%)	0 of 18 (0%)	Not reported

Limitations and caveats (from the sponsor): non-closure of macular hole after surgical procedure in 18 patients led to re-operation. Data included in main published papers.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 19912135Christensen UC. Value of internal limiting membrane peeling in surgery for idiopathic macular hole and the correlation between function and retinal morphology. Acta Ophthalmol. 2009 Dec;87 Thesis 2:1-23. doi: 10.1111/j.1755-3768.2009.01777.x.
Derived from this study: PubMed 19692379Christensen UC, Kroyer K, Sander B, Jorgensen TM, Larsen M, la Cour M. Macular morphology and visual acuity after macular hole surgery with or without internal limiting membrane peeling. Br J Ophthalmol. 2010 Jan;94(1):41-7. doi: 10.1136/bjo.2009.159582. Epub 2009 Aug 18.
Derived from this study: PubMed 19578018Kroyer K, Christensen U, la Cour M, Larsen M. Metamorphopsia assessment before and after vitrectomy for macular hole. Invest Ophthalmol Vis Sci. 2009 Dec;50(12):5511-5. doi: 10.1167/iovs.09-3530. Epub 2009 Jul 2.
Derived from this study: PubMed 19028741Christensen UC, Kroyer K, Sander B, Larsen M, Henning V, Villumsen J, la Cour M. Value of internal limiting membrane peeling in surgery for idiopathic macular hole stage 2 and 3: a randomised clinical trial. Br J Ophthalmol. 2009 Aug;93(8):1005-15. doi: 10.1136/bjo.2008.151266. Epub 2008 Nov 21.
Derived from this study: PubMed 18450594Kroyer K, Christensen U, Larsen M, la Cour M. Quantification of metamorphopsia in patients with macular hole. Invest Ophthalmol Vis Sci. 2008 Sep;49(9):3741-6. doi: 10.1167/iovs.07-1452. Epub 2008 Apr 30.

Related trials for Idiopathic Macular Hole

Recruiting
Comparative Study of Decellularized Human Amniotic Membrane Hydrogel and Inverted Internal Limiting Membrane Flap in Idiopathic Large Macular Holes
Macular Holes
Recruiting
Comparison Between Outcomes of Closure of Idiopathic Macular Hole Using Autologus Tenon Capsule Graft and Internal Limiting Membrane Flap Techniques (Pilot Study)
Macular Hole Surgery, ILM Peeling
Enrolling by invitation
Intraocular Gas Tamponade for Treatment of Large Idiopathic Macular Holes
Idiopathic Macular Hole, Macular Hole
Enrolling by invitation
Minimal Vitrectomy and ILM Flap with Sodium Hyaluronate Gel for MH
Macular Hole, Macular Hole Surgery
Recruiting
PEELED INTERNAL LIMITING MEMBRANE REPOSITION
Macular Holes

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.

Morten la Cour, MD,DMSc,EBOD study director

Glostrup Hospital, Department of Ophthalmology

Michael Larsen, MD, DMSc study director

Glostrup Hospital, Department of Ophthalmology

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing macular hole operation in people with Idiopathic Macular Hole, 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 5 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 16 Apr 2014. 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?

Yes. Results are posted in the registry (first posted 16 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Visual Acuity (ETDRS Letters) (time frame: Visual acuity at 12 months). 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 NCT00302328, which also lists 5 linked publications.

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 16 Apr 2014.