Diabetes Mellitus type 2 Cataract
Conditions
Interventions
Phaco-emulsification.
One group will receive phaco=emulsification (cataractoperation), while the other group will not receive the operation (within one year).
Sponsors
The Rotterdam Eye Hospital
PO Box 70030
3000 LM Rotterdam
tel: 010 4017777
Eligibility
Inclusion criteria
Inclusion criteria: 1. Informed consent; 2. Cataract (LOCS-III grading to document severity); 3. Diabetes Mellitus type 2, which is defined as chronic disease leading to high blood glucose levels due to defects either in insulin secretion or in insulin action in the body. Type 2 diabetes refers to an onset past the age of 30 years, regardless of the dependence on insulin; 4. Mild to moderate non-proliferative diabetic retinopathy, as defined by the International Clinical Diabetic Retinopathy Disease Severity Scale: ·Mild NPDRP: microaneurysms only ·Moderate NPDRP: more than just microaneurysms but less than severe NPRDP which includes any of the following: more than 20 intraretinal hemorrhages in each of four quadrants, definite venous beading in 2 or more quadrants, prominent IRMA on 1 or more quadrants; 5. Statines are permitted; 6. Antihypertensive drugs are permitted; 7. All anti-DM drugs are permitted, except Avandia (and derivatives); 8. All anti-aggregantia are permitted.
Exclusion criteria
Exclusion criteria: 1. 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); 2. Any other corneal, media, retinal or optic nerve disorder, except stage I (AREDS) dry ARMD; 3. Clinically significant macular edema (CSME), as defined by the ETDRS as follows: a. Thickening of the retina at or within 500 microns of the center of the macula. b. Hard exudates at or within 500 microns of the center of the macula, if associated with thickening of the adjacent retina (not residual hard exudates remaining after the disappearance of retinal thickening). c. A zone or zones of retinal thickening one disc area or larger, any part of which is within one disc diameter of the center of the macula. 4. Pregnant, no active birth control; 5. Use of Diamox; 6. Use of Avandia (rosiglitazone); 7. Use of oral steroids; 8. Use of Coumarin derivatives and heparin derivatives; 9. Status after ablatio retina/vitrectomy; 10. History of steroid response.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Incidence of DME. DME is defined as an increase in mean foveal thickness on OCT of 30% or more from preoperative baseline. No distinction will be made between Irvine-Gass syndrome or evolving diabetic maculopathy, as it is impossible to differentiate these entities and, moreover, this is clinically not relevant. As such, presence or absence of retinal microauneurysms, retinal exudates or cystoid pattern on OCT will not be taken into account to diagnose DME; 2. Best Corrected Visual Acuity (ETDRS) at baseline, day 1, week 4, 12, 24 and 52; 3. Mean Foveal Thickness (OCT) at baseline, day 1, week 4, 12, 24 and 52. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Intraocular pressure at baseline, day 1, week 4, 12, 24 and 52; 2. Laser Flare Measurement (Laser Flare Cell Meter) at baseline, day 1, week 4 and 12; 3. Fundus photograph (ETDRS Grading) at baseline, week 24 and 52; 4. VFQ-25 and diabetic Questionnaire at baseline, and week 52; 5. Duration of DM will be registered, as well as a complete list of current medication and systemic comorbidity; 6. Phacoemulsification parameters and duration of surgical intervention. | — |
Contacts
Public ContactO. Creten
The Rotterdam Eye Hospital
Outcome results
None listed