Refractive Consequences of Epiretinal Membrane Surgery

NCT02413619 | Completed

• 1 other identifier: EPIREF
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Epiretinal Membrane

Outcome Measures

Primary Outcomes (3)

• Refractive Error

  Prediction error of intraocular lens calculation (measured in diopters)

  One year

• Corneal endothelial count

  measured in number of cells per square millimeter (mm2)

  One year

• Macula anatomy

  Macula-anatomy success of surgery, i.e. the postoperative decrease of macula thickness or postoperative macular oedema. Measured in millimeter.

  One year

Secondary Outcomes (2)

• Anterior Chamber Depth

  One year

• Axial length

  One year

Study Arms (3)

Start cataract

ACTIVE COMPARATOR

Patients start having cataract surgery. After one month they undergo vitrectomy

Procedure: Cataract surgery

start vitrectomy

ACTIVE COMPARATOR

Patients start having vitrectomy. After one month they undergo cataract surgery.

Procedure: Vitrectomy

combined surgery

ACTIVE COMPARATOR

Combined cataract surgery and vitrectomy at the same time

Procedure: Combined surgery

Interventions

Vitrectomy PROCEDURE

Vitrectomy

start vitrectomy

Cataract surgery PROCEDURE

Cataract surgery

Start cataract

Combined surgery PROCEDURE

Combined vitrectomy and cataract surgery at the same time

combined surgery

Eligibility Criteria

• Age: 50 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Glostrup University Hospital, Copenhagen: lead

Study Sites (1)

Eye Department Glostrup Hospital

Glostrup Municipality, DK, 2600, Denmark

Location

MeSH Terms

Conditions

Epiretinal Membrane

Interventions

Vitrectomy; Cataract Extraction

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Refractive Surgical Procedures

Study Officials

• Hassan Hamoudi, MD

  Eye Department Glostrup Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 27, 2015
• First Posted: April 10, 2015
• Study Start: May 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: November 10, 2016

Record last verified: 2016-11

Locations

DK (1)