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A Randomized Controlled Trial to Compare the Safety and Efficacy of Grid Laser Versus Posterior Subtenon Triamcinolone Versus Combined Subtenon Triamcinolone and Grid Laser in the Treatment of Clinically Significant Diabetic Macular Edema

A Randomized Controlled Trial to Compare the Safety and Efficacy of Grid Laser Versus Posterior Subtenon Triamcinolone Versus Combined Subtenon Triamcinolone and Grid Laser in the Treatment of Clinically Significant Diabetic Macular Edema

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-05000666
Enrollment
Unknown
Registered
2005-09-23
Start date
2005-10-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Eye Diseases

Interventions

Two groups:Grid laser photocoagulation versus 1. Posterior subtenon triamcinolone 40mg injection 2. Combined 40mg subtenon TA injection and grid laser, 12 months

Sponsors

Nil
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1. Documented CSME defined according to ETDRS guidelines; 2. Macular thickening =250um in the foveal center measured on ocular coherent tomography (OCT); 3. Patients physically fit ot receive laser photocoagulation or intravitreal injection; 4. Age of at least 18 years; 5. Informed consent.

Exclusion criteria

Exclusion criteria: Exclusion criteria: 1. Macular edema secondary to other causes, including retinal vein or artery occlusion, uveitis, premacular fibrosis, retinitis pigmentosa, macular hole and choroidal neovascularisation; 2. =1 disc diameter of capillary closure at the macula on fluorescein angiography; 3. Signs of vitreomacular traction on either biomicroscopy or OCT examination; 4. Proliferative diabetic retinopathy requiring immediate treatment; 5. History of glaucoma or ocular hypertension; 6. Chronic renal failure maintained on renal dialysis; 7. Previous intraocular surgery (including previous vitrectomy or trabeculectomy) except uncomplicated cataract extraction and posterior intraocular lens insertion; 8. Any cataract extraction or laser procedure within 3 months; 9. Media opacities (including significant cataract which requires cataract removal to improve visual acuity) which affect fundus examination or OCT measurements; 10. Fellow eye of visual acuity =1.7 ETDRS logMAR units; 11. Failure to comply with follow up schedule.

Design outcomes

Primary

MeasureTime frame
Best-corrected visual acuity (ETDRS chart);—

Secondary

MeasureTime frame
1. Macular eduma measured by optical coherent tomogram (OCT) - a non-contact and non-invasive investigation to assess the degree of macular edema. 2. Side effects including a) Intraocular pressure measured by non contact tonometer(NCT); b) Degree of cataract assessed clinically according to the Lens Opacity Classification System (LOCS) III.;—

Countries

China

Contacts

Public ContactProf. Dennis SC Lam
dennislam_cu_res@cuhk.edu.hk+852 27623134

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026