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Completed

NCT Number: NCT02203929

Preoperative Progression of Macular Holes

Knowledge of the natural history and progression of macular holes is mainly limited to the studies from the pre-optical coherence tomography era. By observing macular holes preoperatively we are able to determine the extent of the preoperative macular hole progression.

At our institution macular holes are treated in an elective setting. The majority of macular holes undergo a 2-step sequence of phacoemulsification and intraocular lens implantation followed by vitrectomy.

We wish to observe the effect of time and cataract surgery on the progression of macular holes prior to vitrectomy.

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Key information

Conditions

Macular Holes Disease Attributes Disease Progression Eye Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Retinal Diseases Retinal Perforations

Age range

40 year–120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Glostrup Hospital, University of Copenhagen

Glostrup Municipality, 2600, Denmark

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Idiopathic macular hole stage II-IV
  • Informed consent
  • Duration of symptoms ≤ 24 months

Exclusion criteria

  • Previous vitreomacular surgery
  • Ocular trauma
  • Significant visual function affecting disease (proliferative diabetic retinopathy, diabetic macular edema, exudative macular degeneration)

Treatment and study plan

Primary outcomes

  1. Macular hole Progression

    Time frame: 3 months preoperative

    Serial optical coherence tomography (OCT) measurements in the preoperative period. The size of macular hole is determined by measuring the macular hole minimal linear diameter (µm).

    Size and stage of macular hole is determined at primary evaluation at tertiary ophthalmic center. Initial scan is followed by pre-vitrectomy scan if patient is pseudophakic. Initial OCT scan is followed by pre- and postcataract as well as pre-vitrectomy OCT scan if patient is pseudophakic.

Secondary outcomes

  1. Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity

    Time frame: 3 months postoperative

    Visual acuity in ETDRS letters measured 3 month postoperatively

Sponsors and collaborators

Lead sponsor

Glostrup University Hospital, Copenhagen

Other

Registry information

Official study title

Preoperative Progression of Macular Holes Using Optical Coherence Tomography

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 30, 2014
Registry last updated
Feb 11, 2016

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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