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
  Purpose

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.


Condition Intervention
Macular Hole
Procedure: Vitreous surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Observation of Postoperative Status of Macular Hole in Gas-filled Eyes by Spectral Domain-optical Coherence Tomography

Resource links provided by NLM:


Further study details as provided by Kyorin University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 37
Study Start Date: April 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Macular hole
The patients of idiopathic macular hole enrolled in the study
Procedure: Vitreous surgery
Vitreous surgery is performed to treat the original disease not for the study.
Macular hole retinal detachment
The patients of macular hole retinal detachment enrolled in the study
Procedure: Vitreous surgery
Vitreous surgery is performed to treat the original disease not for the study.
Myopic traction maculopathy
The patients of macular hole with myopic traction maculopathy enrolled in the study
Procedure: Vitreous surgery
Vitreous surgery is performed to treat the original disease not for the study.

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.

  Eligibility

Ages Eligible for Study:   35 Years to 85 Years
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01266746

Locations
Japan
Kyorin Eye Center
Mitaka, Tokyo, Japan, 181-8611
Sponsors and Collaborators
Kyorin University
Investigators
Principal Investigator: Makoto INoue, MD Kyorin Eye Center
  More Information

No publications provided

Responsible Party: Makoto Inoue, Associate professor, Kyorin University
ClinicalTrials.gov Identifier: NCT01266746     History of Changes
Other Study ID Numbers: Kyorineye001, KYORIN-H21012
Study First Received: December 20, 2010
Last Updated: December 31, 2012
Health Authority: Japan: Institutional Review Board

Keywords provided by Kyorin University:
gas tamponade,
macular hole,
macular hole retinal detachment,
optical coherence tomography

Additional relevant MeSH terms:
Retinal Perforations
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on July 29, 2014