Dryness Difference Between Before and After Phacoemulsification

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-12

Study Completion Date

2025-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Watering of the Eyes Following Uneventful Phacoemulsification Cataract Surgery

NCT05683613

Watery Eyes

UNKNOWN

Analysis of Cataract Surgery Induced Dry Eye

NCT01471561

Cataract

COMPLETED

Impact of Cataract Surgery on the Incidence and Progression of Dry Eye Disease

NCT06759168

Dry Eye

NOT_YET_RECRUITING

Anterior Segment Changes After Phacoemulsification in Cataractous Eyes with Shallow Anterior Chamber

NCT06745596

Cataract

COMPLETED NA

Tear Film Evaluation After Phacoemulsification

NCT02238015

Cortical Senile Cataract

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Dry Eye

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dry eye diagnostic system

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes