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CompletedNCT01266746Updated Jan 3, 2013

Optical Coherence Tomography in Gas-filled Eyes

An observational study in Macular Hole, sponsored by Kyorin University. Completed at 1 site in Japan. Open to participants aged 35 Years to 85 Years. Per ClinicalTrials.gov, last updated 2013-01-03.

Sponsored by Kyorin University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
37
Ages
35 Years to 85 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Macular Hole

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Keywords

  • gas tamponade,
  • macular hole,
  • macular hole retinal detachment,
  • optical coherence tomography
03

In context

Retinal Perforations

156 studies on the registry are indexed under Retinal Perforations; 21 are open to participants now.

This study's enrollment of 37 is below the median of 42 across 51 observational studies indexed under Retinal Perforations.

Browse Retinal Perforations studies →

Lead sponsor

Kyorin University is the lead sponsor of 33 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • the patients who had vitreous surgery for other disease
  • the patients who did not have postoperative examination of spectral domain optical coherence tomography
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
37 participants (actual)
Patient registry
No

Groups and cohorts

  • Macular hole

    The patients of idiopathic macular hole enrolled in the study

    Procedure: Vitreous surgery

  • Macular hole retinal detachment

    The patients of macular hole retinal detachment enrolled in the study

    Procedure: Vitreous surgery

  • Myopic traction maculopathy

    The patients of macular hole with myopic traction maculopathy enrolled in the study

    Procedure: Vitreous surgery

Interventions

  • ProcedureVitreous surgery

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

06

What researchers measure

Primary outcomes

  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

    Time frame: Change from preoperative status up to postoperative day 30.

Secondary outcomes

  1. preoperative and postoperative vision

    The preoperative and postoperarive vision are measured.

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

07

Study locations

1 site
  • Kyorin Eye Center
    Mitaka, Tokyo 181-8611, Japan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 3, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01266746
Lead sponsor
Kyorin University
Responsible party
Makoto Inoue (Associate professor, Kyorin University) — Principal investigator
First posted
Dec 24, 2010
Start date
Apr 2009
Primary completion
Aug 2009
Completion
Aug 2009
Last update
Jan 3, 2013

Study contacts

Makoto INoue, MD
principal investigator · Kyorin Eye Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.

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