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Dry EyeNCT06513000

Dryness Difference Between Before and After Phacoemulsification

An observational study of Dry Eye, run by Sohag University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of this study is to compare tear film and tear film secretion before and after phacoemulsificaton cataract surgery Read more about this study

Who is it for?
Ages 45 years and olderHealthy volunteers can take part
Conditions the study is for
Dry Eye
What is being tested?
Dry eye diagnostic system
How many people
100 participants
Where
1 siteEgypt
Study dates
12 Jul 2024to Mar 2025
Phase
Observational
Are there results?
None posted in the registry

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 45 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: this study included 100 cataract patients, with age above 45 years old who underwent uncomplicated phacoemulsification surgery

Who may be able to join

  • Cataract patients.
  • Cases within age > 45 years old.

Who cannot join

  • Patients with ocular surface diseases and eyelid abnormality.
  • Patients receive ocular or systemic medications, that interfere with tear film production and stability (e.g. topical eye drops that contain preservatives, antihistaminic drugs, anticholinergic drugs, contraceptive pills).
  • Patients with systemic diseases like diabetes, HTN, rheumatoid arthritis. - Patients underwent previous ocular surgeries that interfere with tears instability or production (e.g. refractive surgery, keratoplasty, eyelid surgeries, pterygium excision).
  • Patients with a history of trauma, chemical burn, overusing contact lens (due to damaging the conjunctiva and the goblet cells, also corneal sensitivity reduction).

Trial locations and contacts

1 site in 1 country.

Mohamed Samir zayed, Resident contact

01111485309 ext. 002

Doc.sad.2000@gmail.com

Egypt1 site, 1 recruiting
  • Sohag university hospital

    Sohag

    Mohamed Samir, Resident, 01111485309 ext. 002, Doc.sad.2000@gmail.com

    Recruiting

Other trials in Egypt

About this study

Official title: Evaluation Of Dry Eye After Uneventful Phacoemulsification

The aim of this study is to compare tear film and tear film secretion before and after phacoemulsificaton cataract surgery

Read the detailed description

The tear film is a thin fluid layer overlies the ocular surface and provides the interface between the ocular surface and the external environment.

  • It consists of three layers (lipid, aqueous and mucous) which act together to protect the corneal and conjunctival tissues and keeping them healthy.
  • The superficial lipid layer is secreted by meibomian glands and functions as a smooth optical surface, reduces surface tension of the tear film, prevents anterior migration of aqueous tears on to the lid margin and retards evaporation .
  • The Mucous layer is secreted by the goblet cells of the conjunctiva. It contains mucins that is very essential for lubrication, and wetting.
  • The aqueous tear layer is mainly produced by the main lacrimal glands with small amounts produced by the goblet cells in the conjunctiva and accessory lacrimal glands and This layer acts by providing oxygen and nutrients to the avascular corneal tissue, washing away tissue debris, toxins, and foreign bodies, and also protecting the ocular surface from microbes.
  • Cataract is the common cause of vision loss in the developing countries, also its rate of incidence increases with aging. So it is essential for those patients to undergo cataract surgeries to improve their vision and protect them from blindness.
  • Phacoemulsification is the most recent cataract surgery at which a small incision is done then the ultrasonic power is used to fragment and emulsify the cataract. It was first introduced by Dr. Charlies Kelman and now Most surgeons prefer phacoemulsification surgery because of less postoperative astigmatism, faster stabilization of vision and refraction, and less postoperative inflammation
  • Some surgical interventions related to the anterior segment may also cause dry eye and aggravate the symptoms of pre-existing dry eye, like PRK, LASIK, and cataract surgery by extra capsular cataract extraction, because a large incision is created in the eye during the procedure that sometimes damages the cornea and also can occur with phacoemulsification with a smaller incision.
  • There are many tests that are used to estimate the degree of dryness and its severity which measure tear stability, tear production, and the presence of ocular surface disorders like Schirmer's test , which is used to evaluate tear production and the severity of dry eye by estimating the amount of special filter paper wetting that is put in the lower fornix for 5 minutes, and the Tears Break Up Time test, which is important to evaluate the tear film stability and evaporation.
  • In this study we aim to evaluate dry eye affection after phacoemulsification whether it is worsen or not and the degree of increased dryness especially that dry eye syndrome is very common in our community and how phacoemulsification is now a frequent and preferred operation.

After taking a good detailed history The following assessments were performed in each patient before surgery and at the 2-week and 1-, 3-, and 6-month follow-up visits by the following tests:

  1. Non-invasive tear film break up time (TBUT), a parameter of tear film stability.
  2. Non-invasive tear meniscus height.
  3. Evaluation of Meibomian glands function.
  4. Lipid layer thickness.
  5. Eyelid margin.
  6. Analysis of conjunctival hyperemia.
  7. Cornea sodium fluorescein staining.
  • Schirmer I test, a measure of basic and reflex tear secretion, was performed without anesthesia. This test was performed by placing Schirmer strips over the lower lid margin; the strip wetting was measured and recorded in millimeters.
  • Dry eye symptoms patients were classified as having dry eye disease if they reported experiencing one or more of the primary symptoms (soreness, scratchiness, dryness, grittiness, burning) often or constantly, the TBUT value was less than 10 seconds, and in Schirmer test I there is less than 10 mm wetting of filter paper for a period of 6 months or more after surgery.
  • Visual acuity before and after surgery.
  • Anterior segment examination by slit lamp.
Conditions
Dry Eye
Being tested
Dry eye diagnostic system
Medical subject headings
Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dry eye diagnostic systemDiagnostic test

    following tests:

    1. Non-invasive tear film break up time (TBUT), a parameter of tear film stability.
    2. Non-invasive tear meniscus height.
    3. Evaluation of Meibomian glands function.
    4. Lipid layer thickness.
    5. Eyelid margin.
    6. Analysis of conjunctival hyperemia.
    7. Cornea sodium fluorescein staining.
    8. Schirmer I test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation Of Dryness Post Phacoemulcification In Non Complicated Cases using tear film break up time in seconds.

    Analysis of dryness before and after uncomplicated phacoemulsification using tear film break up time in seconds.

    Measured: Before the operation and 2-week and 1, 3, and 6 month after the operation

  2. Evaluation Of Dryness Post Phacoemulcification In Non Complicated Cases using tear meniscus height in millimeters.

    Analysis of dryness before and after uncomplicated phacoemulsification using tear meniscus height in millimeters.

    Measured: Before the operation and 2-week and 1, 3, and 6 month after the operation

  3. Evaluation Of Dryness Post Phacoemulcification In Non Complicated Cases using Lipid layer thickness in nanometers.

    Analysis of dryness before and after uncomplicated phacoemulsification using Lipid layer thickness in nanometers..

    Measured: Before the operation and 2-week and 1, 3, and 6 month after the operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2024
  2. Study start12 Jul 2024
  3. Primary completionFeb 2025 (estimated)
  4. Study completionMar 2025 (estimated)

Resources

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
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06513000
Sponsor's protocol ID
Dryness post phaco
Status last verified
Jul 2024
First submitted
8 Jul 2024
Last updated
22 Jul 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Qin Y, Pan ZQ. [Recent advances in dry eye: etiology, pathogenesis and management]. Zhonghua Yan Ke Za Zhi. 2013 Sep;49(9):857-63. Chinese.

    PubMed 24330938
  • Moss SE, Klein R, Klein BE. Long-term incidence of dry eye in an older population. Optom Vis Sci. 2008 Aug;85(8):668-74. doi: 10.1097/OPX.0b013e318181a947.

    PubMed 18677233
  • Mertzanis P, Abetz L, Rajagopalan K, Espindle D, Chalmers R, Snyder C, Caffery B, Edrington T, Simpson T, Nelson JD, Begley C. The relative burden of dry eye in patients' lives: comparisons to a U.S. normative sample. Invest Ophthalmol Vis Sci. 2005 Jan;46(1):46-50. doi: 10.1167/iovs.03-0915.

    PubMed 15623753
  • Pflugfelder SC, Stern ME. Biological functions of tear film. Exp Eye Res. 2020 Aug;197:108115. doi: 10.1016/j.exer.2020.108115. Epub 2020 Jun 16.

    PubMed 32561483
  • Xue W, Zhu MM, Zhu BJ, Huang JN, Sun Q, Miao YY, Zou HD. Long-term impact of dry eye symptoms on vision-related quality of life after phacoemulsification surgery. Int Ophthalmol. 2019 Feb;39(2):419-429. doi: 10.1007/s10792-018-0828-z. Epub 2018 Feb 1.

    PubMed 29392638

Questions about this trial

What is this clinical trial studying?

An observational study of Dry Eye, run by Sohag University at 1 site in Egypt.

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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mohamed Samir zayed, Resident (01111485309 ext. 002, Doc.sad.2000@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation Of Dryness Post Phacoemulcification In Non Complicated Cases using tear film break up time in seconds. (time frame: Before the operation and 2-week and 1, 3, and 6 month after the operation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06513000, which also lists 5 linked publications.

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 22 Jul 2024.

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Clinical Trial NCT06513000 | AzTrials