Preoperative Progression of Macular Holes

Preoperative Progression of Macular Holes Using Optical Coherence Tomography

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02203929

Enrollment

Registered

2014-07-30

Start date

2014-06-30

Completion date

2015-03-31

Last updated

2016-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular Holes

Keywords

Macular Holes, Progression

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to 120 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Denmark

Outcome results