Dermatochalasis of EyelidNCT05528016
Short and Long-term Results of Skin Versus Skin Plus Orbicularis Resection Blepharoplasty
A study testing Upper Eyelid Blepharoplasty in people with Dermatochalasis of Eyelid and Ocular Surface Disease, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the short and long-term effects of skin-only and skin+muscle excision blepharoplasty on corneal nerves, dry eye parameters, meibomian glands, and eyebrow position. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Dermatochalasis of Eyelid, Ocular Surface Disease, Meibomian Gland Dysfunction
- What is being tested?
- Upper Eyelid Blepharoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2021to 1 Aug 2022
- Phase
- Interventional
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 18.
- Patients with dermatochalasis.
- Patients who were suggested upper eyelid blepharoplasty for medical or cosmetic purposes.
Who cannot join
- Patients who have had previous periorbital or ophthalmic surgery
- Patients with extensive blepharitis
- History of contact lens use
- History of ophthalmic, endocrinological, neurological, or rheumatological diseases
- History of facial paralysis
- Negative Bell's phenomenon
- Schirmer test <5mm
- The patients who had been treated with periocular botulinum toxin in the last 1 year were not included the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University Pendik Research and Educational Hospital
Istanbul, Pendik, 34899
About this study
Official title: Elaborated Analysis of Short and Long-term Results of Skin Versus Skin Plus Orbicularis Resection Blepharoplasty on Corneal Nerves, Meibomian Glands, Dry Eye Parameters, and Eyebrow Position
This study aims to evaluate the short and long-term effects of skin-only and skin+muscle excision blepharoplasty on corneal nerves, dry eye parameters, meibomian glands, and eyebrow position.
Read the detailed description
The study was designed with the approval of the Ethics Committee on Human Research of Marmara University and was conducted following the tenets of the Declaration of Helsinki. Written informed consent was obtained from all patients who received information about the procedure and the postoperative course. The study included 48 eyes of 24 patients older than 18 who applied to Marmara University Oculoplastic and Orbital Surgery Unit due to dermatochalasis and were suggested upper eyelid blepharoplasty for medical or cosmetic purposes. The patients were divided into two groups, Group S (n=12) for skin excision only and Group M (n=12) for skin+muscle excision by the decision of the surgeon. In addition to all ophthalmological examinations, sub-basal nerve plexus parameters with corneal confocal microscopy, Schirmer I test, non-invasive tear break-up time, meibomian gland area loss measurements with infrared meibography, central eyebrow height, and lateral eyebrow height were evaluated at baseline and postoperative 1st week, 1st month and 1st-year follow-ups.
- Conditions
- Dermatochalasis of Eyelid, Ocular Surface Disease, Meibomian Gland Dysfunction, Dry Eye, Brow Ptosis
- Being tested
- Upper Eyelid Blepharoplasty
- Keywords
- blepharoplasty, skin, orbicularis oculi, corneal confocal microscopy, meibomian gland, dry eye, eyebrow
- Medical subject headings
- Meibomian Gland Dysfunction, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper Eyelid BlepharoplastyProcedure or surgery
Blepharoplasty is a procedure that the skin, orbicularis oculi muscle, and fat pads are excised to treat visual field loss caused by dermatochalasis.
| Study group | Role | What they receive |
|---|---|---|
| Skin-Only Blepharoplasty | Active comparator | Only the skin excision was performed for upper eyelid dermatochalasis. Receives: Procedure: Upper Eyelid Blepharoplasty |
| Skin+Muscle Blepharoplasty | Active comparator | Skin plus muscle excision was performed for upper eyelid dermatochalasis. Receives: Procedure: Upper Eyelid Blepharoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal nerve fiber density (CNFD)
Automated tracing of nerve fibers program - CCMetrics (CCMetrics; University of Manchester, Manchester, UK) was used to analyze CNFD in fibers/mm2
Measured: Baseline / 1 Week / 1 Month / 1 Year
Corneal nerve branch density (CNBD)
Automated tracing of nerve fibers program - CCMetrics (CCMetrics; University of Manchester, Manchester, UK) was used to analyze CNBD in branches/mm2.
Measured: Baseline / 1 Week / 1 Month / 1 Year
Corneal nerve fiber length (CNFL)
Automated tracing of nerve fibers program - CCMetrics (CCMetrics; University of Manchester, Manchester, UK) was used to analyze CNBD in mm/mm2.
Measured: Baseline / 1 Week / 1 Month / 1 Year
Eyebrow position
Millimetric measurement was performed to evaluate the effect of blepharoplasty on eyebrow position.
Measured: Baseline / 1 Week / 1 Month / 1 Year
Meibomian Gland Area Loss (MGAL)
Phoenix-Meibography Imaging software that is available in the Sirius® Scheimpflug topographer (Sirius, CSO, Italy) was used to evaluate meibomian gland area loss in percentage.
Measured: Baseline / 1 Week / 1 Month / 1 Year
Non-invasive Tear Break-Up Time (NI-BUT)
Phoenix-Meibography Imaging software that is available in the Sirius® Scheimpflug topographer (Sirius, CSO, Italy) was used to evaluate non-invasive tear break-up time in seconds.
Measured: Baseline / 1 Week / 1 Month / 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start1 May 2021
- Primary completion1 Jul 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dermatochalasis of EyelidStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Volkan Dericioğlu, M.D, Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05528016
- Sponsor's protocol ID
- 09.2022.102
- Status last verified
- Sep 2022
- First submitted
- 31 Aug 2022
- Last updated
- 6 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data supporting the study findings are available from the corresponding author upon request.
Publications
Dericioglu V, San B, Sevik MO, Akkaya Turhan S. Skin-Only Versus Skin-Plus-Orbicularis Resection Blepharoplasty: An Elaborated Analysis of Early- and Long-Term Effects on Corneal Nerves, Meibomian Glands, Dry Eye Parameters, and Eyebrow Position. Ophthalmic Plast Reconstr Surg. 2023 Sep-Oct 01;39(5):479-486. doi: 10.1097/IOP.0000000000002376. Epub 2023 Mar 27.
PubMed 36972140
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elaborated Analysis of Short and Long-term Results of Skin Versus Skin Plus Orbicularis Resection Blepharoplasty on Corneal Nerves, Meibomian Glands, Dry Eye Parameters, and Eyebrow Position
- ClinicalTrials.gov ID
- NCT05528016
- Acronym / sponsor ID
- 09.2022.102
- Conditions
- Dermatochalasis of Eyelid, Ocular Surface Disease, Meibomian Gland Dysfunction, Dry Eye, Brow Ptosis
- Keywords
- blepharoplasty, skin, orbicularis oculi, corneal confocal microscopy, meibomian gland, dry eye, eyebrow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 6 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.
This study aims to evaluate the short and long-term effects of skin-only and skin+muscle excision blepharoplasty on corneal nerves, dry eye parameters, meibomian glands, and eyebrow position.
Detailed description
The study was designed with the approval of the Ethics Committee on Human Research of Marmara University and was conducted following the tenets of the Declaration of Helsinki. Written informed consent was obtained from all patients who received information about the procedure and the postoperative course. The study included 48 eyes of 24 patients older than 18 who applied to Marmara University Oculoplastic and Orbital Surgery Unit due to dermatochalasis and were suggested upper eyelid blepharoplasty for medical or cosmetic purposes. The patients were divided into two groups, Group S (n=12) for skin excision only and Group M (n=12) for skin+muscle excision by the decision of the surgeon. In addition to all ophthalmological examinations, sub-basal nerve plexus parameters with corneal confocal microscopy, Schirmer I test, non-invasive tear break-up time, meibomian gland area loss measurements with infrared meibography, central eyebrow height, and lateral eyebrow height were evaluated at baseline and postoperative 1st week, 1st month and 1st-year follow-ups.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Skin-Only Blepharoplasty | Active comparator | Procedure: Upper Eyelid BlepharoplastyOnly the skin excision was performed for upper eyelid dermatochalasis. |
| Skin+Muscle Blepharoplasty | Active comparator | Procedure: Upper Eyelid BlepharoplastySkin plus muscle excision was performed for upper eyelid dermatochalasis. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients older than 18.
- Patients with dermatochalasis.
- Patients who were suggested upper eyelid blepharoplasty for medical or cosmetic purposes.
Key exclusion criteria (8 listed)
- Patients who have had previous periorbital or ophthalmic surgery
- Patients with extensive blepharitis
- History of contact lens use
- History of ophthalmic, endocrinological, neurological, or rheumatological diseases
- History of facial paralysis
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 Eyelid BlepharoplastyBlepharoplasty is a procedure that the skin, orbicularis oculi muscle, and fat pads are excised to treat visual field loss caused by dermatochalasis. | Procedure or surgery | Skin+Muscle Blepharoplasty, Skin-Only Blepharoplasty |
Primary outcome
Corneal nerve fiber density (CNFD)
Time frame: Baseline / 1 Week / 1 Month / 1 Year
Automated tracing of nerve fibers program - CCMetrics (CCMetrics; University of Manchester, Manchester, UK) was used to analyze CNFD in fibers/mm2
Corneal nerve branch density (CNBD)
Time frame: Baseline / 1 Week / 1 Month / 1 Year
Automated tracing of nerve fibers program - CCMetrics (CCMetrics; University of Manchester, Manchester, UK) was used to analyze CNBD in branches/mm2.
Corneal nerve fiber length (CNFL)
Time frame: Baseline / 1 Week / 1 Month / 1 Year
Automated tracing of nerve fibers program - CCMetrics (CCMetrics; University of Manchester, Manchester, UK) was used to analyze CNBD in mm/mm2.
Eyebrow position
Time frame: Baseline / 1 Week / 1 Month / 1 Year
Millimetric measurement was performed to evaluate the effect of blepharoplasty on eyebrow position.
Meibomian Gland Area Loss (MGAL)
Time frame: Baseline / 1 Week / 1 Month / 1 Year
Phoenix-Meibography Imaging software that is available in the Sirius® Scheimpflug topographer (Sirius, CSO, Italy) was used to evaluate meibomian gland area loss in percentage.
Non-invasive Tear Break-Up Time (NI-BUT)
Time frame: Baseline / 1 Week / 1 Month / 1 Year
Phoenix-Meibography Imaging software that is available in the Sirius® Scheimpflug topographer (Sirius, CSO, Italy) was used to evaluate non-invasive tear break-up time in seconds.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2022.
- Derived from this study: PubMed 36972140Dericioglu V, San B, Sevik MO, Akkaya Turhan S. Skin-Only Versus Skin-Plus-Orbicularis Resection Blepharoplasty: An Elaborated Analysis of Early- and Long-Term Effects on Corneal Nerves, Meibomian Glands, Dry Eye Parameters, and Eyebrow Position. Ophthalmic Plast Reconstr Surg. 2023 Sep-Oct 01;39(5):479-486. doi: 10.1097/IOP.0000000000002376. Epub 2023 Mar 27.
- Individual participant dataSharing planned: No. The data supporting the study findings are available from the corresponding author upon request.
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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.
Volkan Dericioğlu, M.D principal investigator
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Upper Eyelid Blepharoplasty in people with Dermatochalasis of Eyelid and Ocular Surface Disease, run by Marmara University at 1 site in Turkey (Türkiye).
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 3 inclusion and 8 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: finished, as of the sponsor's last update on 6 Sep 2022. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corneal nerve fiber density (CNFD) (time frame: Baseline / 1 Week / 1 Month / 1 Year). The study lists 6 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 NCT05528016, which also lists 1 linked publication.
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 6 Sep 2022.