Neovascular (wet) Age-Related Macular Degenerationit does notNCT06759597
The Effect of Phacoemulsification on the Macular Changes in Patients with Neovascular Age-related Macular Degeneration
An observational study of Neovascular (wet) Age-Related Macular Degeneration, run by Assiut University.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Neovascular (wet) Age-Related Macular Degeneration
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2025to Apr 2026
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: old age population had phacoemulsefcation with history of neovascular AMD
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Macular Changes After Phacoemulsification in Patients with Neovascular AMD
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
Read the 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.
- Medical subject headings
- Macular Degeneration
What is being measured
The primary outcome is the main question the study is designed to answer.
To figure out the possibility of Postoperative conversion or relapse ( Dry to wet , wet to reactivated CNV)
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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start1 Feb 2025 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular (wet) Age-Related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Demiana alkes zakka labib, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06759597
- Sponsor's protocol ID
- Macular Changes after PHE
- Acronym
- it does not
- Status last verified
- Dec 2024
- First submitted
- 30 Dec 2024
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Macular Changes After Phacoemulsification in Patients with Neovascular AMD
- ClinicalTrials.gov ID
- NCT06759597
- Acronym / sponsor ID
- it does not / Macular Changes after PHE
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 6 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- old age population had phacoemulsefcation with history of neovascular AMD
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- intraoperative complications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Neovascular (wet) Age-Related Macular Degeneration, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Demiana Alkes Zakka Labib Demiana Alkes Zakka Labib (+01211418560, demianaalk.1997@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To figure out the possibility of Postoperative conversion or relapse ( Dry to wet , wet to reactivated CNV) (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2025; AzTrials last refreshed its copy on 26 Oct 2026.