Dry EyeNCT06513000
Dryness Difference Between Before and After Phacoemulsification
An observational study of Dry Eye, run by Sohag University at 1 site in Egypt.
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.
Egypt1 site, 1 recruiting
- Recruiting
Sohag university hospital
Sohag
Mohamed Samir, Resident, 01111485309 ext. 002, Doc.sad.2000@gmail.com
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:
- 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.
- 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:
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
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.
- First posted22 Jul 2024
- Study start12 Jul 2024
- Primary completionFeb 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Samir, Sohag University
- Investigators
- Hatem Gamal eldeen, Professor, Study director, Sohag UniversityMahmoud Mohamed farouk, Professor, Study chair, Sohag UniversityHany Mahmoud, Lecturer, Study chair, Sohag UniversityMohamed samir zayed, resident, Principal investigator, Tahta ophthalmology hospital
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 24330938Moss 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 18677233Mertzanis 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 15623753Pflugfelder 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 32561483Xue 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
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Dry Eye After Uneventful Phacoemulsification
- ClinicalTrials.gov ID
- NCT06513000
- Acronym / sponsor ID
- Dryness post phaco
- Conditions
- Dry Eye
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 12 Jul 2024 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 22 Jul 2024 (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 aim of this study is to compare tear film and tear film secretion before and after phacoemulsificaton cataract surgery
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- this study included 100 cataract patients, with age above 45 years old who underwent uncomplicated phacoemulsification surgery
Key inclusion criteria (2 listed)
- Cataract patients.
- Cases within age > 45 years old.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dry eye diagnostic systemfollowing 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 | Diagnostic test | – |
Primary outcome
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.
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.
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..
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- Background: PubMed 24330938Qin Y, Pan ZQ. [Recent advances in dry eye: etiology, pathogenesis and management]. Zhonghua Yan Ke Za Zhi. 2013 Sep;49(9):857-63. Chinese.
- Background: PubMed 18677233Moss 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.
- Background: PubMed 15623753Mertzanis 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.
- Background: PubMed 32561483Pflugfelder 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.
- Background: PubMed 29392638Xue 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.
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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. This study is not recruiting at the moment.
Hatem Gamal eldeen, Professor study director
Sohag University
Mahmoud Mohamed farouk, Professor study chair
Sohag University
Hany Mahmoud, Lecturer study chair
Sohag University
1 site in 1 country: see every site and its status.
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.