Preoperative Progression of Macular Holes

Completed

• Conditions: Macular Holes

• Registration Number: NCT02203929
• Lead Sponsor: Glostrup University Hospital, Copenhagen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-07-28
• Study First Submitted QC: 2014-07-29
• Study First Posted: 2014-07-30
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-10
• Last Update Posted: 2016-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Macular hole Progression	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

Name	Time	Method
Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity	3 months postoperative	Visual acuity in ETDRS letters measured 3 month postoperatively

Trial Locations

Locations (1)

Glostrup Hospital, University of Copenhagen; 🇩🇰 Glostrup, Denmark