Excess Skin of Both EyelidsNCT05549713
The Effect of Upper Blepharoplasty on Vision Quality in the Early Postoperative Period
An observational study of Excess Skin of Both Eyelids and Contrast Sensitivity, run by Osijek University Hospital at 1 site in Croatia.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 90 years
- Conditions the study is for
- Excess Skin of Both Eyelids, Contrast Sensitivity, Tear Film Insufficiency of Both Eyes
- What is being tested?
- Upper blepharoplasty
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteCroatia
- Study dates
- 8 Sep 2022to 1 Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- History of corneal refractive surgery, pterygium, glaucoma, nuclear sclerosis > 4th degree, severe dry eye, age-related macular degeneration, neuro-ophthalmological diseases, use of hormone therapy, diabetic retinopathy or condition after panretinal photocoagulation. Corneal pathologies such as keratoconus and gross eyelid malposition conditions such as entropion, ectropion and marked laxity of the eyelids are also grounds for exclusion from the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Croatia1 site, 1 recruiting
- Recruiting
Osijek University Hospital
Osijek, 31000
Dunja Bajtl, +385981644381
About this study
Official title: The Effect of Upper Blepharoplasty on Anatomical and Functional Aspects of Vision in the Early Postoperative Period
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.
Read more
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.
Read the detailed description
Dermatochalasis is an age-related condition characterized by the development of folds of excess skin on the upper eyelid with loss of skin elasticity. The mechanical pressure created by the accumulation of excess fat tissue and skin over the upper eyelid leads to a feeling of heaviness and narrowing of the peripheral visual field, which is an indication for surgical treatment. In addition to widening the field of vision, it has been noted that upper blepharoplasty (UB) also has an impact on the subjective improvement of vision postoperatively. Although no difference in best corrected visual acuity was observed pre- and postoperatively, it was noted that contrast sensitivity (CS) improves after UB, especially in the late postoperative period, while the same was rarely investigated in the early postoperative period. The exact reason for the postoperative increase in CS is not clear. 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. Functional dermatochalasis is considered excess skin 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. Exclusion criteria are: history of corneal refractive surgery, pterygium, glaucoma, nuclear sclerosis > 4th degree, severe dry eye, age-related macular degeneration, neuro-ophthalmological diseases, use of hormone therapy, diabetic retinopathy or condition after panretinal photocoagulation. Corneal pathologies such as keratoconus and gross eyelid malposition conditions such as entropion, ectropion and marked laxity of the eyelids are also grounds for exclusion from the study.
The external appearance of the upper eyelids of all subjects will be graded in accordance with previous studies. All subjects will have a detailed personal and ophthalmological history taken, and a biomicroscope examination of the anterior segment and fundus. 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 using the Pelli-Robson table, TF analysis and CT (Keratograph 5M, OCULUS Optikgeraete GmbH, Wetzlar, Germany). The CS test will be performed at the University Eye Department, University Hospital Center Osijek (UED), while the TF analysis and CT will be performed at Lens LTD, Zrinjevac 4, 31000 Osijek, completely free of charge. The need for cooperation with Lens LTD arose due to the fact that at UED there is no device for testing the function of the TF, as well as no apparatus for CT. UB will be performed in the operating room at the UED using technique of removing only excess skin without the underlying part of the orbicularis muscle from the upper eyelids. 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. All data will be statistically processed and used in the form of congress announcements and scientific papers in the journal.
- Conditions
- Excess Skin of Both Eyelids, Contrast Sensitivity, Tear Film Insufficiency of Both Eyes, Corneal Topography
- Being tested
- Upper blepharoplasty
- Keywords
- Corneal topography, Contrast sensitivity, Eyelid disease, Meibomian gland dysfunction, Blepharoplasty
- Medical subject headings
- Eyelid Diseases, Meibomian Gland Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper blepharoplastyProcedure or surgery
Upper eyelid surgery in local anesthesia performed by removing excess skin folds and closing with sutures placed on the skin crease.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Upper blepharoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast sensitivity
Measurement of contrast sensitivity using Pelli-Robson chart with best corrected visual acuity in photopic condions
Measured: 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 of corneal topography using Keratograph 5M, OCULUS Optikgeraete GmbH, Wetzlar, Germany
Measured: Measurement will take place preoperatively, 7 days and one month postoperatively. Planned duration of the examination is thirty minutes
Tear film quality
Measurement of tear film quality using Keratograph 5M, OCULUS Optikgeraete GmbH, Wetzlar, Germany
Measured: Measurement will take place preoperatively, 7 days and one month postoperatively. Planned duration of the examination is thirty minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start8 Sep 2022
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Excess Skin of Both EyelidsStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Osijek University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dunja Klepo, Osijek University Hospital
- Investigators
- Dunja Bajtl, Principal investigator, Osijek University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05549713
- Sponsor's protocol ID
- OsijekUH-EYEDEP
- Status last verified
- Dec 2024
- First submitted
- 13 Sep 2022
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 11914706Hacker 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.
PubMed 1476973An 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.
PubMed 27672599Nalci 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.
PubMed 32631001Bhattacharjee 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.
PubMed 33229668Kiang 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.
PubMed 25276652Zhang 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.
PubMed 34881256Soares 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.
PubMed 30304089Zloto 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.
PubMed 31770512Zinkernagel 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.
PubMed 18071108Dogan 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.
PubMed 24409940Simsek 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.
PubMed 26186387Shah 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.
PubMed 23650502
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Upper Blepharoplasty on Anatomical and Functional Aspects of Vision in the Early Postoperative Period
- ClinicalTrials.gov ID
- NCT05549713
- Acronym / sponsor ID
- OsijekUH-EYEDEP
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Osijek University HospitalUniversity, hospital or other
- Study start
- 8 Sep 2022 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 22 Sep 2022 (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.
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.
Detailed description
Dermatochalasis is an age-related condition characterized by the development of folds of excess skin on the upper eyelid with loss of skin elasticity. The mechanical pressure created by the accumulation of excess fat tissue and skin over the upper eyelid leads to a feeling of heaviness and narrowing of the peripheral visual field, which is an indication for surgical treatment. In addition to widening the field of vision, it has been noted that upper blepharoplasty (UB) also has an impact on the subjective improvement of vision postoperatively. Although no difference in best corrected visual acuity was observed pre- and postoperatively, it was noted that contrast sensitivity (CS) improves after UB, especially in the late postoperative period, while the same was rarely investigated in the early postoperative period. The exact reason for the postoperative increase in CS is not clear. 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. Functional dermatochalasis is considered excess skin 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. Exclusion criteria are: history of corneal refractive surgery, pterygium, glaucoma, nuclear sclerosis > 4th degree, severe dry eye, age-related macular degeneration, neuro-ophthalmological diseases, use of hormone therapy, diabetic retinopathy or condition after panretinal photocoagulation. Corneal pathologies such as keratoconus and gross eyelid malposition conditions such as entropion, ectropion and marked laxity of the eyelids are also grounds for exclusion from the study.
The external appearance of the upper eyelids of all subjects will be graded in accordance with previous studies. All subjects will have a detailed personal and ophthalmological history taken, and a biomicroscope examination of the anterior segment and fundus. 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 using the Pelli-Robson table, TF analysis and CT (Keratograph 5M, OCULUS Optikgeraete GmbH, Wetzlar, Germany). The CS test will be performed at the University Eye Department, University Hospital Center Osijek (UED), while the TF analysis and CT will be performed at Lens LTD, Zrinjevac 4, 31000 Osijek, completely free of charge. The need for cooperation with Lens LTD arose due to the fact that at UED there is no device for testing the function of the TF, as well as no apparatus for CT. UB will be performed in the operating room at the UED using technique of removing only excess skin without the underlying part of the orbicularis muscle from the upper eyelids. 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. All data will be statistically processed and used in the form of congress announcements and scientific papers in the journal.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blepharoplasty group | – | Procedure: Upper blepharoplastyAs 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 |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- History of corneal refractive surgery, pterygium, glaucoma, nuclear sclerosis > 4th degree, severe dry eye, age-related macular degeneration, neuro-ophthalmological diseases, use of hormone therapy, diabetic retinopathy or condition after panretinal photocoagulation. Corneal pathologies such as keratoconus and gross eyelid malposition conditions such as entropion, ectropion and marked laxity of the eyelids are also grounds for exclusion from the study.
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 |
|---|---|---|
| Upper blepharoplastyUpper eyelid surgery in local anesthesia performed by removing excess skin folds and closing with sutures placed on the skin crease. | Procedure or surgery | Blepharoplasty group |
Primary outcome
Contrast sensitivity
Time frame: Measurement will take place preoperatively, 7 days and one month postoperatively. Planned duration of the examination is five minutes
Measurement of contrast sensitivity using Pelli-Robson chart with best corrected visual acuity in photopic condions
2 secondary outcomes
Corneal topography
Time frame: Measurement will take place preoperatively, 7 days and one month postoperatively. Planned duration of the examination is thirty minutes
Tear film quality
Time frame: Measurement will take place preoperatively, 7 days and one month postoperatively. Planned duration of the examination is thirty minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- Background: PubMed 11914706DeAngelis DD, Carter SR, Seiff SR. Dermatochalasis. Int Ophthalmol Clin. 2002 Spring;42(2):89-101. doi: 10.1097/00004397-200204000-00009. No abstract available.
- Background: PubMed 1476973Hacker 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.
- Background: PubMed 27672599An 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.
- Background: PubMed 32631001Nalci 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.
- Background: PubMed 33229668Bhattacharjee 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.
- Background: PubMed 25276652Kiang 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.
- Background: PubMed 34881256Zhang 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.
- Background: PubMed 30304089Soares 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.
- Background: PubMed 31770512Zloto 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.
- Background: PubMed 18071108Zinkernagel 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.
- Background: PubMed 24409940Dogan 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.
- Background: PubMed 26186387Simsek 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.
- Individual participant dataSharing planned: No
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.
Dunja Bajtl principal investigator
Osijek University Hospital
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 Excess Skin of Both Eyelids and Contrast Sensitivity, run by Osijek University Hospital at 1 site in Croatia.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 31 Dec 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 Croatia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dunja Bajtl (+385981644381, dunjaklepo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contrast sensitivity (time frame: Measurement will take place preoperatively, 7 days and one month postoperatively. Planned duration of the examination is five minutes). 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 NCT05549713, which also lists 13 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 31 Dec 2024.