Observation of Recovery of Foveal Cone Microstructures After Macular Hole Surgery

Correlation Between Visual Acuity and Recovery of Foveal Cone Microstructures After Macular Hole Surgery

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01306487

Enrollment

Registered

2011-03-02

Start date

2008-03-31

Completion date

2010-08-31

Last updated

2012-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular Holes

Keywords

macular hole

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.

Interventions

PROCEDUREVitrectomy

Macular hole surgery

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
The visual acuity	Preoperative and postoperative 1, 3, 6, 9, 12 months	Preoperative and postoperative best-corrected visual acuity

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026