Clinical trial NCT03944070: Management of Patients With Neovascular Age-related Macular Degeneration Undergoing Cataract Surgery
Official title: Management of Patients With Neovascular Age-related Macular Degeneration Undergoing Cataract Surgery: A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Wet Macular Degeneration
Cataract Extraction
Lead sponsor: Ophthalmica Eye Institute
Sponsor class: OTHER
First posted: 2019-05-09
Enrollment: 16
Sex: ALL
Minimum age (years): 50
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual acuity change from baseline
timeFrame: 12 months
measure: Difference in the number of injections
timeFrame: 12 months
Secondary outcomes:
measure: Status of the macular degeneration based on optical coherence tomography parameter, as compared to baseline
timeFrame: 12 months
Other outcomes:
Locations:
city: Thessaloníki
country: Greece
facility: Ophthalmica Eye Institute
state: Kalamaria
Study officials:
affiliation: Head of Uveitis & Retinal Surgery Department, Ophthalmica Eye Institute
name: Paris G Tranos, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.