Wet Macular Degeneration Clinical Trial
Official title:
Management of Patients With Neovascular Age-related Macular Degeneration Undergoing Cataract Surgery: A Pilot Study
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.
Status | Recruiting |
Enrollment | 16 |
Est. completion date | January 2020 |
Est. primary completion date | January 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 99 Years |
Eligibility |
Inclusion Criteria: - Active choroidal neovascularization (at least 1 intravitreal injection in the past 12 months) associated with AMD and involving the foveal center - BCVA of 1.0 (LogMAR) or better - Duration of wet AMD less than 3 years Exclusion Criteria: - Coexisting ocular pathology potentially affecting visual acuity and/or status of the macula including diabetic retinopathy, advanced glaucoma, retinal vein occlusion, retinal detachment - Newly diagnosed patients with wet AMD who are on anti-VEGF treatment for less than 6 months |
Country | Name | City | State |
---|---|---|---|
Greece | Ophthalmica Eye Institute | Thessaloníki | Kalamaria |
Lead Sponsor | Collaborator |
---|---|
Ophthalmica Eye Institute |
Greece,
Kessel L, Erngaard D, Flesner P, Andresen J, Tendal B, Hjortdal J. Cataract surgery and age-related macular degeneration. An evidence-based update. Acta Ophthalmol. 2015 Nov;93(7):593-600. doi: 10.1111/aos.12665. Epub 2015 Jan 20. Review. — View Citation
Saraf SS, Ryu CL, Ober MD. The effects of cataract surgery on patients with wet macular degeneration. Am J Ophthalmol. 2015 Sep;160(3):487-492.e1. doi: 10.1016/j.ajo.2015.06.006. Epub 2015 Jun 19. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual acuity change from baseline | Difference in visual acuity change from baseline at the end of the follow-up period. | 12 months | |
Primary | Difference in the number of injections | Difference in the number of injections at the end of the follow-up period. | 12 months | |
Secondary | Status of the macular degeneration based on optical coherence tomography parameter, as compared to baseline | The status of the age-related macular degeneration will be evaluated based on optical coherence tomography parameters at the at final follow-up and compared to the baseline. Our main focus is to identify any subfoveal scarring and/ or subfoveal atrophy that may develop during the follow-up and assess changes from the baseline state of the macula. | 12 months |
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