Optical Coherence Tomography in Gas-filled Eyes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Makoto Inoue, Kyorin University
ClinicalTrials.gov Identifier:
NCT01266746
First received: December 20, 2010
Last updated: December 31, 2012
Last verified: December 2012

December 20, 2010
December 31, 2012
April 2009
August 2009   (final data collection date for primary outcome measure)
macular hole closure detected by spectral domain optical coherence tomography [ Time Frame: Change from preoperative status up to postoperative day 30. ] [ Designated as safety issue: Yes ]
The maular hole closure in eyes with intravitreal gas is detected by spectral domain optical coherence tomography
Same as current
Complete list of historical versions of study NCT01266746 on ClinicalTrials.gov Archive Site
preoperative and postoperative vision [ Time Frame: This was a prospective study conducted between April 2009 and August 2009. The vision is measured preoperatively and postoperative day 30. ] [ Designated as safety issue: Yes ]
The preoperative and postoperarive vision are measured.
Same as current
Not Provided
Not Provided
 
Optical Coherence Tomography in Gas-filled Eyes
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

Macular Hole
Procedure: Vitreous surgery
Vitreous surgery is performed to treat the original disease not for the study.
  • Macular hole
    The patients of idiopathic macular hole enrolled in the study
    Intervention: Procedure: Vitreous surgery
  • Macular hole retinal detachment
    The patients of macular hole retinal detachment enrolled in the study
    Intervention: Procedure: Vitreous surgery
  • Myopic traction maculopathy
    The patients of macular hole with myopic traction maculopathy enrolled in the study
    Intervention: Procedure: Vitreous surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
August 2009
August 2009   (final data collection date for primary outcome measure)

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:

  • the patients who had vitreous surgery for other disease
  • the patients who did not have postoperative examination of spectral domain optical coherence tomography
Both
35 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01266746
Kyorineye001, KYORIN-H21012
No
Makoto Inoue, Kyorin University
Kyorin University
Not Provided
Principal Investigator: Makoto INoue, MD Kyorin Eye Center
Kyorin University
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP