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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02413619
Other study ID # EPIREF
Secondary ID
Status Completed
Phase N/A
First received March 27, 2015
Last updated November 9, 2016
Start date May 2014
Est. completion date October 2016

Study information

Verified date November 2016
Source Glostrup University Hospital, Copenhagen
Contact n/a
Is FDA regulated No
Health authority Denmark: Videnskabsetisk comite (ethical comite)
Study type Interventional

Clinical Trial 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.


Description:

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 refraction, slit-lamp examination, fundoscopy and tonometry. Biometry by IOLMaster (Carl Zeiss, Meditec AG, Germany), intraocular power calculation with the SRK/T formula. Pentacam Scheimpflug Cornea tomography (Topcon, Tokyo, Japan). Corneal Endothelial Count obtained by three images of the central region of the corneal endothelium (Topcon SP-3000P, Tokyo, Japan). Heidelberg Optical Coherence Tomography, (Heidelberg Engineering, Heidelberg, Germany).

Sequence of surgery depends on randomization. In all cases a standard phacoemulsification (scleral tunnel or clear corneal incision) with in-the-bag intraocular lens implantation. In combined surgery, the cataract surgery is performed before vitrectomy during the same session. Vitreoretinal procedures include a standard three-port 23 gauge pars plana vitrectomy, membrane peeling, and the use of dyes. Cataract surgery is performed by one of two experienced surgeons, and vitrectomy is carried out by one experienced surgeon.

Analysis: A computer database will be created as a fill-in form to record all patient data, and a masked statistical analysis of all outcome measures will be performed. Statistical analysis will be performed to determine differences in baseline data among the three groups (age, sex, visual acuity, keratometry, axial length, anterior chamber depth, Corneal Endothelial Count). To identify independent predictors for all outcome measures at different follow-up times, multivariate regression analysis is performed. All calculations will be performed using SAS software.


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date October 2016
Est. primary completion date October 2016
Accepts healthy volunteers No
Gender Both
Age group 50 Years to 99 Years
Eligibility Inclusion criteria:

- A diagnosis of Epiretinal membrane,

- visual complaints consistent with Epiretinal membrane,

- age more than 50 years,

- refraction less than ± 5 diopters and astigmatism less than 3 diopters,

- indication for vitrectomy is only Epiretinal membrane.

Exclusion criteria:

- Previous intraocular surgery or laser-refractive procedure.

- Use of intraocular gas tamponade during the vitrectomy.

- Intraoperative manipulation of the intraocular lens.

- Serious complications (endophthalmitis, vitreous haemorrhage or retinal detachment).

- History of previous head or ocular trauma.

- Sulcus fixation of intraocular lens

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Vitrectomy
Vitrectomy
Cataract surgery
Cataract surgery
Combined surgery
Combined vitrectomy and cataract surgery at the same time

Locations

Country Name City State
Denmark Eye Department Glostrup Hospital Glostrup DK

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 Refractive Error Prediction error of intraocular lens calculation (measured in diopters) One year No
Primary Corneal endothelial count measured in number of cells per square millimeter (mm2) One year No
Primary Macula anatomy Macula-anatomy success of surgery, i.e. the postoperative decrease of macula thickness or postoperative macular oedema. Measured in millimeter. One year No
Secondary Anterior Chamber Depth measured in millimeter (mm) One year No
Secondary Axial length measured in millimeter (mm) One year No
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