High-frequency radio-wave electrosurgery versus simple conjunctival resection for conjunctivochalasis
| ISRCTN | ISRCTN20773574 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20773574 |
| Secondary identifying numbers | CMRPG2C0051, CMRPG2C0052 |
- Submission date
- 30/11/2016
- Registration date
- 08/12/2016
- Last edited
- 11/06/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English Summary
Background and study aims
Conjunctivochalasis is a common eye condition where the conjunctiva (the membrane that lines the inside of the eyelids and covers the white of the eye) becomes loose and forms excess folds. This can cause eye irritation, pain, bleeding, watering , dry eye, or ulcers. Currently there are several treatments, such as simple excision (surgery) and high-frequency radio-wave electrosurgery, where an electrode is used to remove excess conjunctiva. The aim of this study is to compare how well these treatments work.
Who can participate?
Patients aged 50 to 100 with conjunctivochalasis
What does the study involve?
Participants are randomly allocated to two groups to undergo either simple excision or high-frequency radio-wave electrosurgery for conjunctivochalasis. They are then followed up for 6 months, during which their eye symptoms are assessed using eye examinations and questionnaires.
What are the possible benefits and risks of participating?
Participants may benefit from relief of their conjunctivochalasis symptoms. The risks of participating are the same as for general eye surface surgery, including bleeding, swelling and infection.
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?
February 2013 to March 2015
Who is funding the study?
Chang Gung Medical Research Foundation (Taiwan)
Who is the main contact?
Dr Ju-Wen Yang
Contact information
Scientific
6F, No.222 Mai-Jin Road
An-Le District
Keelung City
204
Taiwan
 ORCID ID |
0000-0001-5198-9451 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| 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 | A prospective study comparing the efficacy of high-frequency radio-wave electrosurgery versus simple conjunctival resection for treatment of conjunctivochalasis |
| Study hypothesis | Conjunctivochalasis (CCh) is a common cause of ocular surface irritation in older populations. It is defined as redundant and loose inferior bulbar conjunctiva tissue interposed between the globe and the lower eyelid. CCh causes insufficient tear drainage and delayed tear clearance. In tear-sufficient eyes, CCh may present with intermittent epiphora. In dry eyes, it may exacerbate dry eye-related inflammation. High-frequency radio-wave electrosurgery is a minimally invasive procedure to treat symptomatic conjunctivochalasis (CCh). Theoretically, it provides an effective treatment for CCh. The aim of this study is to study compare the efficacy of high-frequency radio-wave electrosurgery versus simple conjunctival resection for treatment of conjunctivochalasis. |
| Ethics approval(s) | Ethics Committee at the Chang Gung Memorial Hospital, 26/11/2012, ref: 100-2782A3 |
| Condition | Conjunctivochalasis |
| Intervention | Patients are randomized into two groups according to their medical record numbers. The even numbers receive high-frequency radio-wave electrosurgery (Group I) and the odd numbers receive simple conjunctival resection (Group II). Before surgery, all cases undergo a full medical and ocular history and a detailed ocular examination, including measurement of (best corrected) visual acuity, intraocular pressure measurement, slit-lamp examination and photography, fluorescein staining, tear break-up time and Schirmer test. Conjunctivochalasis is graded preoperatively and postoperatively on the basis of the grading system (Grade 0 =no persistent fold; Grade 1 = a single, small fold; Grade 2 = ≧ 2 folds, but not higher than the tear meniscus; Grade 3 = multiple folds and higher than the tear meniscus) proposed by Meller and Tseng. Grading is done separately for the temporal, middle, and nasal areas of the conjunctiva. Epiphora and dry eye symptoms are specifically evaluated. Dry eye symptoms are assessed with the Ocular Surface Disease Index (OSDI; Allergan, Inc., Irvine, CA,) a 12-item questionnaire designed to assess the severity of symptoms. The 12 items of the OSDI questionnaire are graded on a scale of 0 to 4: 0 = never; 1 = some of the time; 2 = half of the time; 3 = most of the time; and 4 = all the time. The total OSDI score is then calculated with the following formula: OSDI = ([sum of scores for all questions answered] x 100)/([total number of questions answered] x 4). Thus, the OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. After the procedure, patients was examined postoperatively after 1 week, 1 month, 3 months and 6 months. During each postoperative visit, changes in the patients’ symptoms are recorded in addition to routine examinations and photography. At 3 months and 6 months after the surgery, the patient's symptoms are reassessed with the OSDI. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Conjunctivochalasis, assessed by slit lamp examination using the grading system proposed by Meller and Tseng at baseline, 1 week, 1 month, 3 months and 6 months 2. Dry eye symptoms, assessed with the Ocular Surface Disease Index (OSDI) score at baseline, 3 months and 6 months |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 01/02/2013 |
| Overall study end date | 01/03/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 10 |
| Participant inclusion criteria | 1. Adult patients aged 50 to 100 with symptomatic CCh 2. Willing to receive surgical treatment |
| Participant exclusion criteria | 1. History of conjunctival surgery 2. Nasolacrimal duct obstruction 3. Without consent |
| Recruitment start date | 19/03/2013 |
| Recruitment end date | 01/09/2014 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
204
Taiwan
Sponsor information
Research organisation
Department of Medical Research
No.200, Ln. 208, Jijin 1st Rd., Anle Dist.
Keelung City
204
Taiwan
"ROR" |
https://ror.org/02verss31 |
|---|
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 31/12/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The results will be published in an ophthalmic medical journal as soon as possible. |
| IPD sharing plan | The datasets generated and/or analysed during the current study are available from Dr Ju-Wen Yang on reasonable request. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 07/12/2016 | 04/01/2017 | No | No |
Additional files
- ISRCTN20773574_BasicResults_07Dec16.docx
- Uploaded 04/01/2017
Editorial Notes
11/06/2018: Intention to publish date updated from 30/09/2017 to 31/12/2019.
04/01/2017: Basic results summary added.
