Optical Coherence Tomography in Gas-filled Eyes

NCT ID: NCT01266746

Last Updated: 2013-01-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 37 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2009-08-31

Brief 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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Macular hole

The patients of idiopathic macular hole enrolled in the study

Vitreous surgery

Intervention Type: PROCEDURE

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

Vitreous surgery

Intervention Type: PROCEDURE

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

Vitreous surgery

Intervention Type: PROCEDURE

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

Interventions

Vitreous surgery

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

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kyorin University

OTHER

Sponsor Role: lead

Responsible Party

Makoto Inoue

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Makoto INoue, MD

Role: PRINCIPAL_INVESTIGATOR

Kyorin Eye Center

Locations

Kyorin Eye Center

Mitaka, Tokyo, Japan

Countries

Japan

Other Identifiers

KYORIN-H21012

Identifier Type: OTHER

Identifier Source: secondary_id

Kyorineye001

Identifier Type: -

Identifier Source: org_study_id