Observation of Recovery of Foveal Cone Microstructures After Macular Hole Surgery

Completed

• Conditions: Macular Holes
• Interventions: Procedure: Vitrectomy

• Registration Number: NCT01306487
• Lead Sponsor: Kyorin University

Brief Summary

The objective is to determine whether a recovery of the microstructures of the foveal photoreceptors after macular hole (MH) closure is correlated with the best-corrected visual acuity (BCVA) is determined.

Detailed Description

Macular hole patients were evaluated by spectral domain optical coherence tomography (SD-OCT) to determine the integrity of the microstructures of the foveal photoreceptors. The inner segment/outer segment (IS/OS) junction, the external limiting membrane (ELM), and the cone outer segment tips (COST) line were determined preoperatively, and at 1, 3, 6, 9, and 12 months after the MH surgery. The correlation between the integrity of the foveal photoreceptor microstructures and the best-corrected visual acuity (BCVA) was determined.

Study Timeline

• Study Start: 2008-03
• Primary Completion: 2009-08
• Study Completion: 2010-08
• Study First Submitted: 2011-03-01
• Study First Submitted QC: 2011-03-01
• Study First Posted: 2011-03-02
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-31
• Last Update Posted: 2012-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• The patients had undergone surgery from March 2008 to August 2009 at Kyorin Eye Center
• Idiopathic macular hole patients with either a Stage 2, 3, or 4 according to the Gass classification

Exclusion Criteria

• The presence of other retinal diseases including a treated rhegmatogenous retinal detachment, diabetic retinopathy
• High myopia with an axial length > 27.0 mm or refractive error > -8.0 diopters
• The patients followed for less than 6 months postoperatively

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Macular hole patients	Vitrectomy	The patients who underwent vitreous surgery for idiopathic macular hole.

Primary Outcome Measures

Name	Time	Method
Foveal microstructure determined by optical coherence tomography	Preoperative and postoperative 1, 3, 6, 9, 12 months	The integrity of the microstructures of the foveal photoreceptors; the inner segment/outer segment (IS/OS) junction, the external limiting membrane (ELM), and the cone outer segment tips (COST) line were determined by spectral domain optical coherence tomography.

Secondary Outcome Measures

Name	Time	Method
The visual acuity	Preoperative and postoperative 1, 3, 6, 9, 12 months	Preoperative and postoperative best-corrected visual acuity

Trial Locations

Locations (1)

Kyorin Eye Center; 🇯🇵 Mitaka, Tokyo, Japan