Observation of Recovery of Foveal Cone Microstructures After Macular Hole Surgery

Macular Holes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01306487
• Other study ID #: Kyorineye002
• Status: Completed
• Phase: N/A
• First received: March 1, 2011
• Last updated: July 31, 2012
• Start date: March 2008
• Est. completion date: August 2010

Study information

• Verified date: July 2012
• Source: Kyorin University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: August 2010
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Macular Holes
• Retinal Perforations

Intervention

Procedure:
• Vitrectomy
Macular hole surgery

Locations

Country	Name	City	State
Japan	Kyorin Eye Center	Mitaka	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Kyorin University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Foveal microstructure determined by optical coherence tomography	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.	Preoperative and postoperative 1, 3, 6, 9, 12 months	No
Secondary	The visual acuity	Preoperative and postoperative best-corrected visual acuity	Preoperative and postoperative 1, 3, 6, 9, 12 months	No