Dryness Difference Between Before and After Phacoemulsification

NCT06513000 | Recruiting

• 1 other identifier: Dryness post phaco
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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..

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

Interventions

Dry eye diagnostic system DIAGNOSTIC_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

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag university hospital

Sohag, Egypt

RECRUITING

Related Publications (5)

• 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.

  PMID: 24330938 BACKGROUND

• 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.

  PMID: 18677233 BACKGROUND

• 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.

  PMID: 15623753 BACKGROUND

• 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.

  PMID: 32561483 BACKGROUND

• 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.

  PMID: 29392638 BACKGROUND

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Hatem Gamal eldeen, Professor

  Sohag University

  STUDY DIRECTOR

• Mahmoud Mohamed farouk, Professor

  Sohag University

  STUDY CHAIR

• Hany Mahmoud, Lecturer

  Sohag University

  STUDY CHAIR

• Mohamed samir zayed, resident

  Tahta ophthalmology hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Samir zayed, Resident

CONTACT

01111485309; Doc.sad.2000@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 22, 2024
• Study Start: July 12, 2024
• Primary Completion: February 1, 2025
• Study Completion: March 1, 2025
• Last Updated: July 22, 2024

Record last verified: 2024-07

Locations

EG (1)