Condition category
Eye Diseases
Date applied
18/03/2020
Date assigned
10/05/2020
Last edited
18/05/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Mr Chauyin Chen

ORCID ID

Contact details

6
Sec
West
Chia Pu Road
Pu Zih City
Chiayi
61363
Taiwan
+886 (0)975353261
m7043@cgmh.org.tw

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

201801039B0D001

Study information

Scientific title

Using a modified Quickert procedure combined with prolapsed fat removal to correct involutional lower eyelid entropion in Asians

Acronym

Study hypothesis

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

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

Study design

Retrospective observational cross-sectional cohort study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

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

Phase

Drug names

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 trial start date

04/07/2018

Overall trial end date

03/01/2019

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150

Total final enrolment

97

Participant 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

Recruitment start date

01/01/2012

Recruitment end date

31/10/2017

Locations

Countries of recruitment

Taiwan

Trial participating centre

Chang Gung Memorial Hospital
Department of Ophthalmology 6, Sec, West, Chia Pu Road, Pu Zih City
Chiayi
61363
Taiwan

Sponsor information

Organisation

Chiayi Chang Gung Memorial Hospital

Sponsor details

6
Sec
West
Chia Pu Road
Chiayi City
61363
Taiwan
+886 (0)5 3621000
m7043@cgmh.org.tw

Sponsor type

Hospital/treatment centre

Website

https://www.cgmh.org.tw/branch/branch_jia.htm

Funders

Funder type

Hospital/treatment centre

Funder name

Chiayi Chang Gung Memorial Hospital

Alternative name(s)

Chia-Yi Chang-Gong Memorial Hospital, Chang Gung Memorial Hospital, Chia-Yi

Funding Body Type

private sector organisation

Funding Body Subtype

Other non-profit organizations

Location

Taiwan

Results and Publications

Publication and dissemination plan

Planned publication in an ophthamology or plastic surgery journal

IPD sharing statement
The datasets generated and/or analyzed during the current study during this study will be included in the subsequent results publication.

Intention to publish date

01/01/2020

Participant level data

Other

Basic results (scientific)

See additional files

Publication list

Publication citations

Additional files

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.