Outcomes of Subthreshold Laser Versus Intravitreal Injection of Ranibizumab in Diabetic Macular Edema
- Conditions
- Diabetic Macular Edema
- Interventions
- Procedure: laser interference,INTRAVITREAL INJECTION
- Registration Number
- NCT04332133
- Lead Sponsor
- Minia University
- Brief Summary
The aim of this study is To compare the anatomical and functional results of intravitreal( IV) injection of ranibizumab with sub threshold micropulse laser ( SML) in treatment of Diabetic macular edema (DME) both anatomically by spectral domain optical coherence tomography (SD OCT) and functionally by best-corrected visual acuity (BCVA) and multifocal electroretinogram (mfERG).
- Detailed Description
Diabetic macular edema (DME) causes significant visual loss in diabetic patients. About 20% and 40% of patients with Type 1 and Type 2 diabetes mellitus (DM), respectively, develop DME. One-third of diabetic patients who have had DM for more than twenty years will develop DME . Early impairment in the function of the middle and inner layers of the retina has been reported in diabetic patients before appearance of vascular complications . A good independent guide of macular function in patients with DME is multifocal electroretinogram (mfERG) readings from the macular area, which strongly associate with morphologic alterations in the macula. Some investigators suggested that temporal characteristic (implicit time) of mfERG waves are more important than amplitudes for evaluation of retinal function in diabetic patients. They concluded that patients with DM show temporal changes indicating delayed neural transmission due to local impairment of blood glucose metabolism. In contrast, others emphasize the importance of both parameters (implicit time and amplitude) in identifying retinal affection in DM.
Intravitreal (IV) injections of anti-vascular endothelial growth factor (VEGF) agents provided good visual outcomes in treatment of DME. However, IV anti-VEGF injections are expensive, need to be repeated many times and have the potential risk of causing endophthalmitis . Subthreshold micropulse laser (SML) treatment of DME has the same effect as conventional laser treatment, nonetheless, there is less damage to adjacent tissues of the burn area in the retinal pigment epithelium (RPE). SML allows laser emission to be divided into bursts of short cyclic pulses that remain for microseconds permitting substantial cooling amid these short pulses .
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- DME with BCVA<0.5 decimal Snellen acuity.
- Controlled blood glucose (HbA1c) <6.5%.
- History of previous intraocular surgery,
- History of previous laser treatment,
- History of previous IV injection,
- Macular disease or ischemia,
- Proliferative diabetic retinopathy,
- Vitreoretinal traction,
- Interruption of external limiting membrane (ELM) or ellipsoid zone (EZ).
- Dense media opacity,
- Optic disc pathology
- History of strokes or ischaemic heart diseases.
- patients with (CST) > 400 µm on OCT .
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description group 1 laser interference,INTRAVITREAL INJECTION group 1 of DME which treated by SML group 2 laser interference,INTRAVITREAL INJECTION Group 2 of DME which treated by intravitreal injection of Ranibizumab
- Primary Outcome Measures
Name Time Method p1 amplitude of mfERG 6mnths p1 amplitude of multifocal ERG measured in nv/deg2
central subfield thickness in micrometer 6 months OCT for the macular area with measuring CST in micron
BCVA 6 months BCVA is measured in decimal of Snellen visual acuity
- Secondary Outcome Measures
Name Time Method