Observation of Recovery of Foveal Cone Microstructures After Macular Hole Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Makoto Inoue, Kyorin University
ClinicalTrials.gov Identifier:
NCT01306487
First received: March 1, 2011
Last updated: July 31, 2012
Last verified: July 2012

March 1, 2011
July 31, 2012
March 2008
August 2009   (final data collection date for primary outcome measure)
Foveal microstructure determined by optical coherence tomography [ Time Frame: Preoperative and postoperative 1, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01306487 on ClinicalTrials.gov Archive Site
The visual acuity [ Time Frame: Preoperative and postoperative 1, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
Preoperative and postoperative best-corrected visual acuity
Same as current
Not Provided
Not Provided
 
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

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Retrospective
Not Provided
Not Provided
Probability Sample

Consecutive patients with surgically-closed MHs after successful vitrectomy

Macular Holes
Procedure: Vitrectomy
Macular hole surgery
Other Name: Optical coherence tomography
Macular hole patients
The patients who underwent vitreous surgery for idiopathic macular hole.
Intervention: Procedure: Vitrectomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58
August 2010
August 2009   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01306487
Kyorineye002
No
Makoto Inoue, Kyorin University
Kyorin University
Not Provided
Not Provided
Kyorin University
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP