A modified surgical approach for treating lower eyelid inversion (entropion) in Asian patients
| ISRCTN | ISRCTN39804797 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39804797 |
| Secondary identifying numbers | 201801039B0D001 |
- Submission date
- 18/03/2020
- Registration date
- 10/05/2020
- Last edited
- 18/05/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
Lower eyelid involutional entropion causes the eyelid margin and eyelashes to rotate inward and irritate the eye. It usually occurs in individuals above 50 years of age. Many surgical methods have been designed to correct the contributing factors, but even so, recurrence is still a troublesome complication. To reduce the risk for recurrence, surgeons have modified the procedures according to the patients. The type of surgical procedure to be adopted should also be determined according to racial anatomical differences. Therefore, researchers have proposed a new surgical method modified from the Quickert procedure. This surgical design can cover most of the triggering causes in Asians. The aim of this study is to review the outcomes of patients who have undergone this surgery during the past five years (from January 2012 to October 2017).
Who can participate?
Patients aged over 55 years who had been diagnosed with involutional entropion and underwent the new surgical technique for repair
What does the study involve?
Information is collected from each patient’s medical record including surgical success, complications and recurrence. All surgical procedures and examinations are performed by a single oculoplastic surgeon (CY Chen) using consistent techniques.
What are the possible benefits and risks of participating?
The surgical procedure was modified from the Quickert procedure in some steps, and the Quickert procedure has been well confirmed in the correction of lower lid entropion. The modified surgical procedure is thought to be safe and effective, and result in less recurrence, overcorrection and complication.
Where is the study run from?
Chang Gung Memorial Hospital (Taiwan)
When is the study starting and how long is it expected to run for?
July 2018 to January 2019
Who is funding the study?
Chang Gung Memorial Hospital (Taiwan)
Who is the main contact?
Chauyin Chen
m7043@cgmh.org.tw
ccy423@gmail.com
Contact information
Scientific
6 , Sec, West, Chia Pu Road, Pu Zih City
Chiayi
61363
Taiwan
| Phone | +886 (0)975353261 |
|---|---|
| m7043@cgmh.org.tw |
Study information
| Study design | Retrospective observational cross-sectional cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Using a modified Quickert procedure combined with prolapsed fat removal to correct involutional lower eyelid entropion in Asians |
| Study objectives | The researchers propose a new surgical method modified from Quickert procedure. This surgical design can cover most of the triggering causes in Asians. |
| Ethics approval(s) | Approved 04/07/2018, Chang Gung Medical Foundation Institutional Review Board (199, Tung Hwa North Road, Taipei, Taiwan, 10507, Republic Of China; +886 (0)3 3196200; ccyi@cgmh.org.tw), IRB No.: 201801039B0 |
| Health condition(s) or problem(s) studied | Involutional lower eyelid entropion |
| Intervention | Every outpatient receiving the modified Quickert procedure is arranged regular follow-ups at the outpatient clinic at the time of pre-op, 1 week and 2 months after surgery, and then when needed according to the patient's other chronic eye diseases. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Success rate: successful surgery was defined as a normal eyelid position at rest, and inability to induce entropion by provocative test. Success rate was measured using external eye photography and provocative test performed in clinic, measured at follow-up after 2 months, and also after 12 months for patients when needed due to their other ocular diseases |
| Secondary outcome measures | Measured at follow-up after 2 months, and also after 12 months for patients when needed due to their other ocular diseases: 1. Recurrence rate: recurrence defined as either the majority of eyelashes remained in contact with the globe or persistent irritation/keratitis in the presence of residual in-turned eyelashes 2. Overcorrection rate: overcorrection defined as ectropion and conjunctiva inside out 3. Complication rate: complication defined as formation of symblepharon, wound infection or wound dehiscence during the follow-up period |
| Overall study start date | 04/07/2018 |
| Completion date | 03/01/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 150 |
| Total final enrolment | 97 |
| Key inclusion criteria | 1. Patients aged > 55 years 2. Involutional lower eyelid entropion confirmed by the presenting of trichiasis, eyelid laxity, vertical laxity, and abundant of orbicularis |
| Key exclusion criteria | 1. Patients with concurrent eyelid pathologies such as malignant tumor, cicatricial entropion caused by trauma, infection or inflammatory, spastic entropion caused by essential blepharospasm, hemifacial spasm-involutional entropion 2. Post-operative follow-up period of < 2 months 3. Aged < 55 years at the time of surgery 4. Patients with any history of previous surgery for involutional entropion |
| Date of first enrolment | 01/01/2012 |
| Date of final enrolment | 31/10/2017 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
6, Sec, West, Chia Pu Road, Pu Zih City
Chiayi
61363
Taiwan
Sponsor information
Hospital/treatment centre
6, Sec, West, Chia Pu Road
Chiayi City
61363
Taiwan
| Phone | +886 (0)5 3621000 |
|---|---|
| m7043@cgmh.org.tw | |
| Website | https://www.cgmh.org.tw/branch/branch_jia.htm |
"ROR" |
https://ror.org/04gy6pv35 |
Funders
Funder type
Hospital/treatment centre
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Chia-Yi Chang-Gong Memorial Hospital, Chang Gung Memorial Hospital, Chia-Yi
- Location
- Taiwan
Results and Publications
| Intention to publish date | 01/01/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in an ophthamology or plastic surgery journal |
| IPD sharing plan | The datasets generated and/or analyzed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 29/04/2020 | 18/05/2020 | No | No |
Additional files
- ISRCTN39804797_BasicResults_29Apr20.pdf
- uploaded 18/05/2020
Editorial Notes
18/05/2020: The basic results of this trial have been uploaded as an additional file.
14/04/2020: Trial's existence confirmed by the Chang Gung Medical Foundation Institutional Review Board.
