NCT03944070

Management of Patients With Neovascular Age-related Macular Degeneration Undergoing Cataract Surgery

Management of Patients With Neovascular Age-related Macular Degeneration Undergoing Cataract Surgery: A Pilot Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Ophthalmica Eye Institute · Academic / Other
• Sex: All
• Age: 50 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

To-date there have been only very few studies to examine the effect of cataract surgery to patients with wet age-related macular degeneration. The evidence on the effects of cataract surgery in such patients suggests improvement of their visual function and quality of life, but at the same time a subclinical susceptibility to macular edema and exacerbation of the choroidal neovascularization. Therefore it is highly important to identify the optimum treatment regime, pursuing the best anatomical and functional postoperative results.

Detailed description

To-date there have been only very few studies to examine the effect of cataract surgery to patients with neovascular age-related macular degeneration (AMD), especially in the era of anti-vascular endothelial growth factor (anti-VEGF) therapy. Furthermore the issue of optimum treatment regimen that should be used in the peroperative period has never been addressed. Since the human life expectancy gradually increases, the number of patients who are under anti-VEGF intravitreal injections for wet AMD will be increasing accordingly. Cataract surgery in such patients, despite guarded prognosis has been proved to improve their visual function and quality of life. On the other hand, it has been shown that cataract surgery induces anatomic changes based on optical coherence tomography analysis, suggesting a subclinical susceptibility to postoperative cystoid macular edema or exacerbation of choroidal neovascularization. Therefore it is highly important to identify the optimum treatment regime, pursuing the best anatomical and functional postoperative results.

Conditions

• Wet Macular Degeneration
• Cataract Extraction

Interventions

Type	Name	Description
DRUG	Ranibizumab	Intravitreal Ranibizumab is approved for the treatment of wet AMD. In this study we will compare an intensive injection protocol versus the standard treat and extend protocol in wet AMD patients undergoing cataract surgery.

Timeline

• Start date: 2018-01-01
• Primary completion: 2020-01-01
• Completion: 2020-01-01
• First posted: 2019-05-09
• Last updated: 2019-05-09

Locations

1 site across 1 country: Greece