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Preoperative Progression of Macular Holes

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ClinicalTrials.gov Identifier: NCT02203929
Recruitment Status : Completed
First Posted : July 30, 2014
Last Update Posted : February 11, 2016
Sponsor:
Information provided by (Responsible Party):
Mark Alberti, Glostrup University Hospital, Copenhagen

Study Description
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Brief Summary:

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.


Condition or disease
Macular Holes

Study Design
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Study Type : Observational
Actual Enrollment : 37 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Preoperative Progression of Macular Holes Using Optical Coherence Tomography
Study Start Date : June 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015
Groups and Cohorts
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Group/Cohort
Phakic eyes
Phakic eyes will be monitored with 4 preoperative optical coherence tomography scans as these patients will undergo phacoemulsification and intraocular lens implantation prior to their macular hole surgery
Pseudophakic eyes
Phakic eyes will be monitored with 2 preoperative optical coherence tomography scans as there is no surgical intervention prior to the macular hole treatment.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity [ Time Frame: 3 months postoperative ]
    Visual acuity in ETDRS letters measured 3 month postoperatively


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Tertiary Ophthalmic University Center
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02203929


Locations
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Denmark
Glostrup Hospital, University of Copenhagen
Glostrup, Denmark, 2600
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
Investigators
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Study Director: Morten la Cour, DMSc Glostrup University Hospital, Copenhagen
More Information
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Responsible Party: Mark Alberti, BSc.med., Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier: NCT02203929    
Other Study ID Numbers: MH-Progression
First Posted: July 30, 2014    Key Record Dates
Last Update Posted: February 11, 2016
Last Verified: February 2016
Keywords provided by Mark Alberti, Glostrup University Hospital, Copenhagen:
Macular Holes
Progression
Additional relevant MeSH terms:
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Retinal Perforations
Disease Progression
Disease Attributes
 Pathologic Processes
Retinal Diseases
Eye Diseases