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
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|
|Study Type :||Observational|
|Actual Enrollment :||37 participants|
|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|
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
Phakic eyes will be monitored with 2 preoperative optical coherence tomography scans as there is no surgical intervention prior to the macular hole treatment.
- 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.
- Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity [ Time Frame: 3 months postoperative ]Visual acuity in ETDRS letters measured 3 month postoperatively
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02203929
|Glostrup Hospital, University of Copenhagen|
|Glostrup, Denmark, 2600|
|Study Director:||Morten la Cour, DMSc||Glostrup University Hospital, Copenhagen|