Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Cataract
  • Diabetic Macular Edema
Type
Interventional
Phase
Phase 3
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Cataract is very common in diabetic patients and can lead to significant vision loss and disability without medical intervention. Diabetic patients, particularly those with diabetic macular edema (DME), experience poorer visual outcomes after undergoing cataract surgery compared to non-diabetics. An...

Cataract is very common in diabetic patients and can lead to significant vision loss and disability without medical intervention. Diabetic patients, particularly those with diabetic macular edema (DME), experience poorer visual outcomes after undergoing cataract surgery compared to non-diabetics. An increased risk in the development of post-operative cystoid macular edema and exacerbation of baseline DME is reported and this poses a significant challenge in managing concomitant DME and visually-significant cataracts. Goals of the study are to evaluate how different timing of anti-VEGF intravitreous injections (before operation, intra-operation or after-operation) affect visual acuity (BCVA) in patients with persistent diabetic macular edema who are undergoing cataract surgery; and to evaluate how different timing of anti-VEGF intravitreous injections affect OCT CSF thickness and total number of postoperative injections in patients with diabetic macular edema who are undergoing cataract surgery.

Tracking Information

NCT #
NCT04063358
Collaborators
Not Provided
Investigators
Principal Investigator: wei shen Changhai Hospital