Preoperative Progression of Macular Holes

Macular Holes Clinical Trial

Official title:

Preoperative Progression of Macular Holes Using Optical Coherence Tomography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02203929
• Other study ID #: MH-Progression
• Status: Completed
• Phase: N/A
• First received: July 28, 2014
• Last updated: February 10, 2016
• Start date: June 2014
• Est. completion date: March 2015

Study information

• Verified date: February 2016
• Source: Glostrup University Hospital, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 120 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Macular Holes
• Retinal Perforations

Locations

Country	Name	City	State
Denmark	Glostrup Hospital, University of Copenhagen	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Glostrup University Hospital, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Macular hole Progression	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.	3 months preoperative	No
Secondary	Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity	Visual acuity in ETDRS letters measured 3 month postoperatively	3 months postoperative	No