The Effect of Upper Blepharoplasty on Vision Quality in the Early Postoperative Period

NCT05549713 | Recruiting

• 1 other identifier: OsijekUH-EYEDEP
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Contrast sensitivity (CS) and tear film (TF) changes are noted in late postoperative period after upper blepharoplasty (UB), while the same was rarely investigated in the early postoperative period. The reason for aforementioned improvement of vision quality is unclear. Suggested explanations include changes in higher-order aberrations, elimination of the overlay effect created by excess skin on the upper eyelids and/or eyelashes directed toward the eyelid, or changes in corneal topography (CT) and keratometry. Furthermore, there is no consensus on the best technique for UB. Due not only to different surgical techniques, but also to different methods of measuring the tear film quality, it is very difficult to quantify the aforementioned studies. While changes in tear volume parameters and changes in tear film (TF) rupture have been investigated in detail, changes in the lipid layer have rarely been investigated. According to previous studies, there are different findings about changes in CT after UB. The aim of the research is to determine whether there are anatomical (CT) and functional (TF and CS) changes in subjects with functional dermatochalasis before the procedure and in a month-long postoperative period. The research is conducted on examinees diagnosed by clinical examination with functional dermatochalasis with the exclusion of examinees with ocular or systemic conditions affecting TF, best corrected visual acuity or CT. Detailed medical history and ophthalmologic examination will be performed with grading of the external appearance of the upper eyelids. All diseases and conditions that can lead to changes in CS, TF or corneal defects will be noted. Preoperatively all subjects will have CS recorded in photopic conditions, TF analysis and CT (Keratograph 5M, OCULUS Optikgeraete GmbH, Wetzlar, Germany). UB will be performed in the operating room at the UED. At first (seven days postoperatively) and second (one month postoperative) check-up a CS check will be performed at the UED and TF analysis and CT at Lens LTD.

Conditions

Excess Skin of Both Eyelids; Contrast Sensitivity; Tear Film Insufficiency of Both Eyes; Corneal Topography

Keywords

Corneal topography; Contrast sensitivity; Eyelid disease; Meibomian gland dysfunction; Blepharoplasty

Outcome Measures

Primary Outcomes (1)

• Contrast sensitivity

  Measurement of contrast sensitivity using Pelli-Robson chart with best corrected visual acuity in photopic condions

  Measurement will take place preoperatively, 7 days and one month postoperatively. Planned duration of the examination is five minutes

Secondary Outcomes (2)

• Corneal topography

  Measurement will take place preoperatively, 7 days and one month postoperatively. Planned duration of the examination is thirty minutes

• Tear film quality

  Measurement will take place preoperatively, 7 days and one month postoperatively. Planned duration of the examination is thirty minutes

Study Arms (1)

Blepharoplasty group

As a single arm study, all examinees will undergo upper blepharoplasty. Data regarding corneal topography, tear film quality and contrast sensitivity will be obtained before the surgery, seven days and one month postoperatively

Procedure: Upper blepharoplasty

Interventions

Upper blepharoplasty PROCEDURE

Upper eyelid surgery in local anesthesia performed by removing excess skin folds and closing with sutures placed on the skin crease.

Blepharoplasty group

Eligibility Criteria

• Age: 45 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Examinees complaining of subjective difficulties due to excess skin on the upper eyelid. All examinees will be examined in University Eye Department, University Hospital Osijek

You may qualify if:

• Patients with functional dermatochalasis on the upper eyelid with subjective difficulties due to obstructing the upper part of visual field: swelling of the eyelids in the morning with difficulties in opening the eyes, use of the frontal musculature to be able to have at least a partial width of the field of vision in the upper part that is adequate for daily functioning, and headaches.

Sponsors & Collaborators

• Osijek University Hospital: lead

Study Sites (1)

Osijek University Hospital

Osijek, 31000, Croatia

RECRUITING

Related Publications (13)

• DeAngelis DD, Carter SR, Seiff SR. Dermatochalasis. Int Ophthalmol Clin. 2002 Spring;42(2):89-101. doi: 10.1097/00004397-200204000-00009. No abstract available.

  PMID: 11914706 BACKGROUND

• Hacker HD, Hollsten DA. Investigation of automated perimetry in the evaluation of patients for upper lid blepharoplasty. Ophthalmic Plast Reconstr Surg. 1992;8(4):250-5. doi: 10.1097/00002341-199212000-00003.

  PMID: 1476973 BACKGROUND

• An SH, Jin SW, Kwon YH, Ryu WY, Jeong WJ, Ahn HB. Effects of upper lid blepharoplasty on visual quality in patients with lash ptosis and dermatochalasis. Int J Ophthalmol. 2016 Sep 18;9(9):1320-4. doi: 10.18240/ijo.2016.09.15. eCollection 2016.

  PMID: 27672599 BACKGROUND

• Nalci H, Hosal MB, Gunduz OU. Effects of Upper Eyelid Blepharoplasty on Contrast Sensitivity in Dermatochalasis Patients. Turk J Ophthalmol. 2020 Jun 27;50(3):151-155. doi: 10.4274/tjo.galenos.2019.95871.

  PMID: 32631001 BACKGROUND

• Bhattacharjee K, Misra D, Singh M, Deori N. Long-term changes in contrast-sensitivity, corneal topography and higher-order aberrations after upper eyelid blepharoplasty: A prospective interventional study. Indian J Ophthalmol. 2020 Dec;68(12):2906-2910. doi: 10.4103/ijo.IJO_907_20.

  PMID: 33229668 BACKGROUND

• Kiang L, Deptula P, Mazhar M, Murariu D, Parsa FD. Muscle-sparing blepharoplasty: a prospective left-right comparative study. Arch Plast Surg. 2014 Sep;41(5):576-83. doi: 10.5999/aps.2014.41.5.576. Epub 2014 Sep 15.

  PMID: 25276652 BACKGROUND

• Zhang S, Yan Y, Lu Y, Zhou Y, Fu Y. Effect of Transcutaneous Upper Eyelid Blepharoplasty on Blink Parameters and Lipid Layer Thickness. Front Med (Lausanne). 2021 Nov 22;8:732041. doi: 10.3389/fmed.2021.732041. eCollection 2021.

  PMID: 34881256 BACKGROUND

• Soares A, Faria-Correia F, Franqueira N, Ribeiro S. Effect of superior blepharoplasty on tear film: objective evaluation with the Keratograph 5M - a pilot study. Arq Bras Oftalmol. 2018 Nov./Dec.;81(6):471-474. doi: 10.5935/0004-2749.20180094. Epub 2018 Oct 8.

  PMID: 30304089 BACKGROUND

• Zloto O, Matani A, Prat D, Leshno A, Ben Simon G. The Effect of a Ptosis Procedure Compared to an Upper Blepharoplasty on Dry Eye Syndrome. Am J Ophthalmol. 2020 Apr;212:1-6. doi: 10.1016/j.ajo.2019.11.021. Epub 2019 Nov 23.

  PMID: 31770512 BACKGROUND

• Zinkernagel MS, Ebneter A, Ammann-Rauch D. Effect of upper eyelid surgery on corneal topography. Arch Ophthalmol. 2007 Dec;125(12):1610-2. doi: 10.1001/archopht.125.12.1610.

  PMID: 18071108 BACKGROUND

• Dogan E, Akbas Kocaoglu F, Yalniz-Akkaya Z, Elbeyli A, Burcu A, Ornek F. Scheimpflug imaging in dermatochalasis patients before and after upper eyelid blepharoplasty. Semin Ophthalmol. 2015 May;30(3):193-6. doi: 10.3109/08820538.2013.839803. Epub 2014 Jan 10.

  PMID: 24409940 BACKGROUND

• Simsek IB, Yilmaz B, Yildiz S, Artunay O. Effect of Upper Eyelid Blepharoplasty on Vision and Corneal Tomographic Changes Measured By Pentacam. Orbit. 2015;34(5):263-7. doi: 10.3109/01676830.2015.1057292. Epub 2015 Jul 17.

  PMID: 26186387 BACKGROUND

• Shah M, Lee G, Lefebvre DR, Kronberg B, Loomis S, Brauner SC, Turalba A, Rhee DJ, Freitag SK, Pasquale LR. A cross-sectional survey of the association between bilateral topical prostaglandin analogue use and ocular adnexal features. PLoS One. 2013 May 1;8(5):e61638. doi: 10.1371/journal.pone.0061638. Print 2013.

  PMID: 23650502 BACKGROUND

MeSH Terms

Conditions

Eyelid Diseases; Meibomian Gland Dysfunction

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Dunja Bajtl

  Osijek University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dunja Bajtl

CONTACT

+385981644381; dunjaklepo@gmail.com

Study Design

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

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: September 22, 2022
• Study Start: September 8, 2022
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: December 31, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)