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Triamcinolone and Macula Grid Laser for Diffuse Diabetic Macular Edema

Triamcinolone and Macula Grid Laser for Diffuse Diabetic Macular Edema - Triamcinolone and Macula Grid Laser for Diffuse Diabetic Macular Edema

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON29703
Enrollment
60
Registered
2006-07-03
Start date
2006-05-01
Completion date
Unknown
Last updated
2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetic retinal edema exsudative diabetic retinopathy

Interventions

Group 1: Posterior sub-Tenon injection of Triamcinolonacetonide (20 mg in 0,5 ml) followed after 1 month by Macula Grid Laser (Argon Green laser). Group 2: Intravitreal injection of Triamcinolonacet

Sponsors

Universitair Medisch Centrum Sint Radboud
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age > 18 jaar Diabetes Mellitus I or II Clinically Significant macular Edema (

Exclusion criteria

Exclusion criteria: Mainly focal leakage from microaneurysms Mainly cystoid leakage Proliferative Diabetic Retinopathy Previous Macula Gridlaser Panretinal photocoagulation 22 mm Hg Glaucoma and/or steroïdresponder Age related macula degeneration, uveïtis Vitreomacular traction and/or macula pucker (fundoscopically and/or OCT) Macula ischaemia (enlargement or irregular foveal avascular zone and/or 6 clock hours of macular capillary nonperfusion on fluorescein angiography) Other ocular disease where intraocular surgery is needed. Chronic renal failure with need for dialysis or renal transplant Allergy for Triamcinolonacetonide

Design outcomes

Primary

MeasureTime frame
Change in mean ETDRS visual acuity 6 months after Macula Grid Laser and change in macular thickness measured by OCT compared to the situation before treatment.

Secondary

MeasureTime frame
Change in visual acuity. Subjective change in visual acuity. Laserenergy needed for minimal visible effect. Incidence of side effects as rise in intraocular pressure, cataract formation, endophthalmitis, retinal detachment. Amount of leakage on fluorescein angiography.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)