To identify the relative risk of ME following cataract surgery in patients with DM type 2 and mild to moderate non-proliferative diabetic retinopathy, compared to diabetics type 2 not undergoing cataract surgery.
ID
Source
Brief title
Condition
- Retina, choroid and vitreous haemorrhages and vascular disorders
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Incidence DME, BCVA, foveal thickness.
Secondary outcome
IOP.
Background summary
Diabetic Macular Edema (DME) is a frequent complication in patients with
diabetes mellitus (DM), especially in late onset (type 2) diabetes. Moreover,
it is frequently observed that DME occurs, recurs or progresses after cataract
surgery. As cataract surgery is the most frequently performed surgical
intervention (20% of over 65 pt and 50% of over 75 pt) and a substantial part
of the elderly population in developed countries develops diabetes mellitus
type 2 (over 1 in 6 persons over 65 year), a significant group of patients
undergoing cataract surgery is at risk for developing DME.
Although several interventional studies have been conducted to prevent
postoperative macular edema in DM type 2 patients, they are characterised by
their relative small numbers and disregarding the diabetic retinopathy (DRP)
stage. Moreover, it is not exactly known what the risk of DME is after cataract
surgery. Therefore, this study evaluates the relative risk of developing
macular edema in diabetic patients with mild to moderate non proliferative
diabetic retinopathy (NPDRP) after cataract extraction, compared to diabetics
not undergoing surgery. Furthermore, this study may serve as a baseline for
future studies evaluating medical intervention to reduce postoperative macular
edema in diabetics.
Study objective
To identify the relative risk of ME following cataract surgery in patients with
DM type 2 and mild to moderate non-proliferative diabetic retinopathy, compared
to diabetics type 2 not undergoing cataract surgery.
Study design
Prospective, open-label, randomized.
Intervention
Group 1: No intervention; Group 2: Phaco-emulsification, Dexamethason collyre
3/d.
Study burden and risks
For patients of group 1, cataract surgery will be suspended. The prolongation
of hampered vision may be experienced as inconvenient; the risk of developing
DME will be reduced during that period. For patients of group 2 the situation
is reversed.
Schiedamse Vest 180
3011 BH Rotterdam
Nederland
Schiedamse Vest 180
3011 BH Rotterdam
Nederland
Listed location countries
Age
Inclusion criteria
- Informed consent
- Cataract
- Diabetes Mellitus type 2
- Mild to moderate non-proliferative diabetic retinopathy
Exclusion criteria
- Severity of cataract obstructing ophthalmic inspection (i.e. NO5, NC5, NO6, NC6, C5, P5) and/or (sufficiently accurate) OCT measurements (i.e. a Signal Strength Index < 35).
- Any other corneal, media, retinal or optic nerve disorder, except stage I dry ARMD
- Clinically significant macular edema
- Pregnant, no active birth control
- Use of Diamox
- Use of Avandia (rosiglitazone)
- Use of oral steroids
- Use of Coumarin derivatives and heparin derivatives
- Status after ablatio retina/vitrectomy
- History of steroid response
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL28882.078.09 |