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OpenTrials
Completed

NCT Number: NCT01381965

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

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.

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Key information

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Makoto Inoue

Mitaka, Tokyo, 181-8611, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitreous surgery for macular hole

Procedure

Vitreous surgery for macular hole

Primary outcomes

  1. Visual acuity

    Time frame: one year

    Preoperative, postoperative 1, 3, 6, 9, 12 months

Secondary outcomes

  1. Integrity of cone outer segment tips line

    Time frame: one year

    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

Sponsors and collaborators

Lead sponsor

Kyorin University

Other

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Jun 27, 2011
Registry last updated
Aug 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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