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NCT Number: NCT06513000

Dryness Difference Between Before and After Phacoemulsification

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

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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sohag university hospital

Sohag, Egypt

Location status: Recruiting

Location contact

Mohamed Samir, Resident

CONTACT

[email protected]

01111485309 ext. 002

About this study

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:

  • Non-invasive tear film break up time (TBUT), a parameter of tear film stability.
  • Non-invasive tear meniscus height.
  • Evaluation of Meibomian glands function.
  • Lipid layer thickness.
  • Eyelid margin.
  • Analysis of conjunctival hyperemia.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

  • 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).

Treatment and study plan

Dry eye diagnostic system

Diagnostic Test

following tests:

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

Primary outcomes

  1. 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

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

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

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

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

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

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

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

Study contacts

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

Mohamed Samir zayed, Resident

CONTACT

[email protected]

01111485309 ext. 002

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

Evaluation Of Dry Eye After Uneventful Phacoemulsification

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 22, 2024
Registry last updated
Jul 22, 2024

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

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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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