Clinical trial NCT02413619: Refractive Consequences of Epiretinal Membrane Surgery
Official title: Refractive Consequences of Epiretinal Membrane Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epiretinal Membrane
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
First posted: 2015-04-10
Enrollment: 62
Sex: ALL
Minimum age (years): 50
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Refractive Error
timeFrame: One year
measure: Corneal endothelial count
timeFrame: One year
measure: Macula anatomy
timeFrame: One year
Secondary outcomes:
measure: Anterior Chamber Depth
timeFrame: One year
measure: Axial length
timeFrame: One year
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Eye Department Glostrup Hospital
state: DK
Study officials:
affiliation: Eye Department Glostrup Hospital
name: Hassan Hamoudi, MD
role: PRINCIPAL_INVESTIGATOR
References: