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Not yet recruiting NCT06759597

The Effect of Phacoemulsification on the Macular Changes in Patients with Neovascular Age-related Macular Degeneration

Observational Neovascular (wet) Age-Related Macular Degeneration

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Neovascular (wet) Age-Related Macular Degeneration. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Macular Changes After Phacoemulsification in Patients with Neovascular AMD

Overview

The macula has a very high concentration of photoreceptor cells - the cells that detect light. They send signals to the brain, which interprets them as images. The rest of the retina processes our peripheral, or side vision To explore whether cataract surgery evokes development or relapse of choroidal neovascularization (CNV) in wet age-related macular degeneration (AMD) patients followed for a 1-year postoperative period

Detailed description

Age-related macular degeneration (AMD) is a leading cause of vision loss in adults over the age of 50. AMD causes damage to a small part of the retina responsible for central vision called the macula. When damage to the macula occurs, it typically causes loss of central, detailed vision which results in difficulty with tasks such as reading, driving, threading a needle, or recognizing faces.

Phacoemulsification is a modern-day cataract surgery that employs ultrasound energy to emulsify the nucleus, vacuum to catch the nuclear material, and irrigation and aspiration for cortex and viscoelastic removal.

It is currently impossible to draw definitive conclusions whether phacoemulsification (PhE) is safe for people with age-related macular degeneration (ARMD). It is not clear if PhE causes the progression of ARMD and affects visual acuity (VA). The purpose was to analyze the possible association of PhE with ARMD progression in the early and late (up to 18 months after surgery) period.

Primary outcome measures

  • To figure out the possibility of Postoperative conversion or relapse ( Dry to wet , wet to reactivated CNV) [Time frame: baseline]

Eligibility criteria

Inclusion Criteria:Subjects included in this study aged above 50 and presented for routine check up after undergoing phacoemulsification:

  • Above 50 years old
  • not diabetic individuals
  • wet ARMD

Exclusion criteria

  • intraoperative complications
  • Eyes with diseases predisposing them for postoperative macular edema, preexisting macular edema, and eyes that developed cystoid macular edema
  • active ocular inflammation or infection \_glaucoma
  • A preoperatively worsened VA regardless phE
  • ocular trauma
  • patients with central retinal ischemia
  • previous vitrectomy
  • dry amd

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06759597 · Macular Changes after PHE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗