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Macular HoleNCT01266746

Optical Coherence Tomography in Gas-filled Eyes

An observational study of Macular Hole, run by Kyorin University at 1 site in Japan.

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

The aim of this study is to determine the condition to detect the status of a macular hole by spectral domain optical coherence tomography (SD-OCT) in gas-filled eyes. The macular area is scanned by SD-OCT (OCT-4000, Carl Zeiss Meditec) in the patients who underwent vitreous surgery for macular hole to detect macular… Read more about this study

Who is it for?
Ages 35 to 85 years
Conditions the study is for
Macular Hole
What is being tested?
Vitreous surgery
Type of treatment
Surgery or procedure
How many people
37 participants
Where
1 siteJapan
Study dates
Apr 2009to Aug 2009
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 35 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The patients who had a vitreous surgery for macular hole, macular hole retinal detachment, myopic traction maculopathy and examined spectral domain optical coherence tomography preoperatively and postoperatively.

Who may be able to join

  • the patients who had a vitreous surgery for macular hole, macular hole retinal detachment, macular hole with myopic traction maculopathy and examined spectral domain optical coherence tomography preoperatively and postoperatively.

Who cannot join

  • the patients who had vitreous surgery for other disease
  • the patients who did not have postoperative examination of spectral domain optical coherence tomography

Trial locations and contacts

1 site in 1 country.

Japan1 site
  • Kyorin Eye Center

    Mitaka, Tokyo, 181-8611

Other trials in Japan

About this study

Official title: Clinical Observation of Postoperative Status of Macular Hole in Gas-filled Eyes by Spectral Domain-optical Coherence Tomography

The aim of this study is to determine the condition to detect the status of a macular hole by spectral domain optical coherence tomography (SD-OCT) in gas-filled eyes. The macular area is scanned by SD-OCT (OCT-4000, Carl Zeiss Meditec) in the patients who underwent vitreous surgery for macular hole to detect macular jole closure on postoperative days 1, 3, 7, and 30.

Read the detailed description

We studied 26 eyes with an idiopathic macular hole (MH), 7 eyes with a MH retinal detachment (MHRD), and 4 eyes with a MH with myopic traction maculopathy. This was a prospective study conducted between April 2009 and August 2009 at the Kyorin Eye Center of the Kyorin University School of Medicine, Tokyo, Japan. The age, gender, laterality of the diseased eye, stage of MH based on the Gass classification, and Snellen best-corrected visual acuity (BCVA) were recorded. The axial length was measured with the OA1000 (TOMEY Corp., Nagoya, Japan) preoperatively in eyes with MH and postoperatively in eyes with MHRD and myopic traction maculopathy to avoid the effect of retinal detachment on the axial length. The presence of a posterior staphyloma within the posterior vascular arcade was determined by ophthalmoscopy and ultrasonography (Ultrascan®, Alcon Laboratories, Fort Worth, TX).

Standard pars plana vitrectomy was performed. The internal limiting membrane (ILM) was removed after making it visible with triamcinolone acetonide (Kenacort-A®, Bristol Pharmaceuticals KK, Tokyo, Japan) or indocyanine green (Santen Pharmacy, Osaka, Japan) in all eyes. Preoperative cataracts were graded as mild (nuclear sclerosis 1+) or moderate to advanced (nuclear sclerosis 2+ or 3+), and phacoemulsification with implantation of an intraocular lens was performed on all cataractous eyes higher than grade 1. Room air, 20% sulfur hexafluoride (SF6), or 14% perfluoropropane (C3F8) was used to tamponade the retina. When the MH was confirmed to be closed in the patients with a idiopathic MH, the face-down position was discontinued although the patients were instructed to avoid an upright position. Patients with MHRD and myopic traction maculopathy were instructed to keep a facedown position for one to two weeks even after a MH closure was detected.

All surgery was performed under retrobulbar anesthesia, and a written informed consent was obtained from all patients after a full explanation of the purpose and possible complications of the treatment. The study protocol was approved by the Institutional Review Committee of the Kyorin University School of Medicine and all of the patients approved the clinical review of their medical records.

The entire macular area was scanned by SD-OCT (OCT4000, Cirrus HD-OCT, Carl Zeiss Medic Inc., Dublin, California, USA) in the sitting position to avoid missing a MH. The 5-line raster mode was used to obtain high quality images on postoperative days 1, 3, 7, and 30. When a macular image could not be obtained, the patients were instructed to look slightly downward or upward until a clearer view of the macular area was obtained in the OCT images. The ability to detect a closed MH or the status of the foveal detachment or schisis by the SD-OCT was evaluated, and the pre- and postoperative factors that affected the OCT images were investigated. The volume of intravitreal gas was estimated by the level of the inferior gas meniscus at the retina with an indirect ophthalmoscope in a sitting position.

Conditions
Macular Hole
Being tested
Vitreous surgery
Keywords
gas tamponade,, macular hole,, macular hole retinal detachment,, optical coherence tomography
Medical subject headings
Retinal Perforations

What participants receive

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

  • Vitreous surgeryProcedure or surgery

    Vitreous surgery is performed to treat the original disease not for the study.

Study groups in NCT01266746
Study groupRoleWhat they receive
Macular holeThe patients of idiopathic macular hole enrolled in the study
Receives: Procedure: Vitreous surgery
Macular hole retinal detachmentThe patients of macular hole retinal detachment enrolled in the study
Receives: Procedure: Vitreous surgery
Myopic traction maculopathyThe patients of macular hole with myopic traction maculopathy enrolled in the study
Receives: Procedure: Vitreous surgery

What is being measured

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

  1. macular hole closure detected by spectral domain optical coherence tomography

    The maular hole closure in eyes with intravitreal gas is detected by spectral domain optical coherence tomography

    Measured: Change from preoperative status up to postoperative day 30.

Secondary outcomes (1)
  1. preoperative and postoperative vision

    The preoperative and postoperarive vision are measured.

    Measured: This was a prospective study conducted between April 2009 and August 2009. The vision is measured preoperatively and postoperative day 30.

Timeline

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

  1. First posted24 Dec 2010 (estimated)
  2. Study startApr 2009
  3. Primary completionAug 2009
  4. Study completionAug 2009

Resources

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
Cohort
Time perspective
Prospective
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01266746
Sponsor's protocol ID
Kyorineye001
Other IDs
KYORIN-H21012
Status last verified
Dec 2012
First submitted
20 Dec 2010
Last updated
3 Jan 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Macular Hole, run by Kyorin University at 1 site in Japan.

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 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 3 Jan 2013. 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 Japan. 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?

macular hole closure detected by spectral domain optical coherence tomography (time frame: Change from preoperative status up to postoperative day 30.). 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 3 Jan 2013.

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