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NCT Number: NCT06759597

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

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

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. To figure out the possibility of Postoperative conversion or relapse ( Dry to wet , wet to reactivated CNV)

    Time frame: baseline

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Demiana Alkes Zakka Labib Demiana Alkes Zakka Labib

CONTACT

[email protected]

+01211418560

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Macular Changes After Phacoemulsification in Patients with Neovascular AMD

Acronym: it does not

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 6, 2025
Registry last updated
Jan 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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