Preoperative Progression of Macular Holes

NCT02203929 | Completed

• 1 other identifier: MH-Progression
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Macular Holes

Keywords

Macular Holes; Progression

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity

  3 months postoperative

Study Arms (2)

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.

Eligibility Criteria

• Age: 40 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Tertiary Ophthalmic University Center

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Glostrup University Hospital, Copenhagen: lead

Study Sites (1)

Glostrup Hospital, University of Copenhagen

Glostrup Municipality, 2600, Denmark

Location

MeSH Terms

Conditions

Retinal Perforations; Disease Progression

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Morten la Cour, DMSc

  Glostrup University Hospital, Copenhagen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: BSc.med.

Study Record Dates

• First Submitted: July 28, 2014
• First Posted: July 30, 2014
• Study Start: June 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: February 11, 2016

Record last verified: 2016-02

Locations

DK (1)