Foveal Cone Outer Segment Resumption to Predict Visual Recovery After Macular Hole Surgery

Macular Holes Clinical Trial

Official title:

Foveal Cone Outer Segment Resumption to Predict Visual Recovery After Macular Hole Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01381965
• Other study ID #: Kyorineye006
• Secondary ID: KYORIN-H21012
• Status: Completed
• Phase: N/A
• First received: June 21, 2011
• Last updated: July 31, 2012
• Start date: March 2008
• Est. completion date: February 2011

Study information

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

Clinical Trial Summary

Spectral domain optical coherence tomography (SD-OCT) was used to determine whether the repair of photoreceptor cone outer segment tips defect is significantly correlated with the visual outcomes after macular hole surgery.

Description:

Spectral domain optical coherence tomography (SD-OCT) was used to calculate the mean length of photoreceptor cone outer segment tips (COST) defect on 1, 3, 6, 9, and 12 months after macular hole surgery. The correlation between the mean length of COST defect and the BCVA was determined. Prognostic factors might have influenced for COST repair was also evaluated by multivariable analysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: February 2011
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

Inclusion Criteria:

• macular hole patients with surgically-closed hole

Exclusion Criteria:

• macular hole patients failed to close hole

• presence of retinal diseases including a treated rhegmatogenous retinal detachment, diabetic retinopathy, and high myopia with an axial length >27.0mm or refractive error > -8.0 diopters(D).

• patients who were not followed at least 6 months

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Macular Holes
• Retinal Perforations

Intervention

Procedure:
• Vitreous surgery for macular hole
Vitreous surgery for macular hole

Locations

Country	Name	City	State
Japan	Makoto Inoue	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	Visual acuity	Preoperative, postoperative 1, 3, 6, 9, 12 months	one year	No
Secondary	Integrity of cone outer segment tips line	The mean length of cone outer segment tips defect on preoperative and postoperative 1, 3, 6, 9, and 12 months with spectral domain optical coherence tomography	one year	No