Clinical Trial: Refractive Consequences of Epiretinal Membrane Surgery

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Refractive Consequences of Epiretinal Membrane Surgery

Brief Summary:

Epiretinal membrane is treated with vitrectomy and peeling. Afterwards cataract is usually developed, which requires a cataract surgery.

The aim of this study is to investigate the refractive consequences of surgery for Epiretinal membrane and cataract.

Investigators investigate the sequence of surgery in patients having surgery for Epiretinal membrane and cataract in a prospective clinically randomized intervention trial. Patients are randomized to 1) start with vitrectomy, 2) start with cataract surgery, 3) combined surgery. Investigators want to find the sequence of surgery that gives the most optimal refractive result, the most stabile intraocular lens, and the minimal loss of corneal endothelial cells.

Detailed Summary:

Aim: To evaluate the impact of the sequence of surgery on the Refractive Error and the Corneal Endothelial Count in phakic individuals undergoing surgery for Epiretinal membrane.

Study design: Prospective interventional randomized clinical trial. Primary outcome: Refractive error (i.e. Intraocular lens power prediction error), Corneal Endothelial Count, and postoperative macular oedema.

Secondary outcome: Changes in axial length, anterior chamber depth and keratometry; the accuracy of formulas used to calculate the power of the intraocular lens.

Study population:

Identification of participants: Individuals referred to the Macular Surgery Clinic, Surgical Retina Team, Department of Ophthalmology, Glostrup University Hospital, Copenhagen, Denmark. The individuals should be signed up for surgery because of Epiretinal membrane at the clinic.

Method:

Individuals are randomized to the possible sequences of surgery (i.e. start with cataract surgery, start with vitrectomy, or combined surgery). Based on an estimated clinical relevant refractive prediction error of 0,50 diopter and a standard deviation of 0,50 diopter, a number of 20 individuals in each of the three groups are needed to obtain a power of 80 % and a type 1 error of 5 %. Total number of individuals is thus 60.

Clinical examinations are performed preoperatively and 2 weeks after each surgery (cataract surgery, vitrectomy or combined surgery), and 3 and 12 months postoperatively. The examinations include best corrected distance visual acuity, autorefraction/keratometry (Retinomax®, Nikon, Tokyo, Japan), subjective refr
Sponsor: Glostrup University Hospital, Copenhagen

Current Primary Outcome:

• Refractive Error [ Time Frame: One year ]
  Prediction error of intraocular lens calculation (measured in diopters)
• Corneal endothelial count [ Time Frame: One year ]
  measured in number of cells per square millimeter (mm2)
• Macula anatomy [ Time Frame: One year ]
  Macula-anatomy success of surgery, i.e. the postoperative decrease of macula thickness or postoperative macular oedema. Measured in millimeter.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Anterior Chamber Depth [ Time Frame: One year ]
  measured in millimeter (mm)
• Axial length [ Time Frame: One year ]
  measured in millimeter (mm)

Original Secondary Outcome: Same as current

Information By: Glostrup University Hospital, Copenhagen

Dates:
Date Received: March 27, 2015
Date Started: May 2014
Date Completion:
Last Updated: November 9, 2016
Last Verified: November 2016