Condition category
Eye Diseases
Date applied
04/06/2014
Date assigned
18/06/2014
Last edited
18/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Cataracts are cloudy patches that develop in the lens of your eye. The lens is a structure that is found just behind your pupil (the black circle of your eye) and it lets in light to the back of your eye (the retina). If the lens becomes cloudy with a cataract, this light cannot get through so efficiently, and this can cause blurred or misty vision. If left untreated, blindness can eventually result. Cataracts are, in fact, the leading cause of impaired vision and blindness worldwide. Postmenopausal women are at a higher risk of developing cataracts when compared to men of the same age group. Scientists think this may because the female sex hormone oestrogen has a protective effect on the eye, helping to prevent cataracts. However, some studies have shown that postmenopausal women currently taking hormone replacement therapy (HRT), or have taken HRT in the past, are at an even higher risk of developing cataracts. Glaucoma is another common eye condition that can lead to impaired vision and blindness. It is caused by a blockage of the eyes drainage tubes (trabecular meshwork). This stops the eye fluid (aqueous humour) from draining properly, leading to an increase in pressure within the eye (intraocular pressure). This can cause damage to the optic nerve and light-sensitive nerve tissue found at the retina. Low oestrogen levels in postmenopausal women puts them at a higher risk of developing glaucoma, but some studies have suggested that HRT helps to prevent this. This study aims look at the effect of HRT on the development of cataracts and glaucoma.

What does the study involve?
Participants are placed into one of two groups. Group 1 includes postmenopausal women who have never used HRT and group 2 includes postmenopausal women who have used HRT continuously for more than 5 years. They will undergo tests over a 6 month period which will measure lens opacity (how cloudy the lens is) and optic nerve cupping (a way to measure possible damage to the optic nerve and loss of nerve fibres), look at the nerve fibres lining the retina (retinal nerve layer Optical Coherence Tomography or OCT), measure serum inflammatory cytokines (a way of measuring inflammation) and antioxidant levels.

Who can take part?
Women who went through the menopause at least 5 years ago.

When does the study take place?
June 2012 to March 2014

Where does the study take place?
The study has been set up by the Bucheon St. Mary's Hospital (South Korea)

What are the possible benefits and risks to participants?
There are no possible benefits or risk to participants.

Who is funding the project?
National Research Foundation of Korea (NRF) - (South Korea)

Who is the main contact?
Professor Eun Chul Kim
eunchol@hanmail.net

Trial website

Contact information

Type

Scientific

Primary contact

Prof Eun Chul Kim

ORCID ID

Contact details

Bucheon St. Mary's Hospital
327 Sosa-ro
Wonmi-gu
Gyeonggi-do
Bucheon
420-717
Korea
South

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

An effect of hormone replacement therapy on cataract and glaucoma in postmenopausal women: A parallel group, case-control study

Acronym

Study hypothesis

Women have been reported to have a lower vision than men of same age. Several studies have reported that postmenopausal women have a higher prevalence of cataract and glaucoma than men of similar age.The definite relationship between gender and cataract prevalence was unclear, but it suggests female sex hormone may play a important role in protecting cataract and glaucoma progression.

Ethics approval

Institutional Review Board (IRB) / Ethics Committee of Bucheon St. Mary Hospital, 3/2/2012, ref. HC13RISI0026

Study design

Parallel group, case-control study

Primary study design

Interventional

Secondary study design

Case-control study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Cataract and glaucoma

Intervention

Hormone replacement therapy

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Cortical, nuclear, and posterior subcapsular density, pentacam nucleus staging (PNS), pentacam densitometry of zone (PDZ) measured by pentacam.

Secondary outcome measures

Antioxidant and inflammatory cytokines activities in serum.

Overall trial start date

01/06/2012

Overall trial end date

01/03/2014

Reason abandoned

Eligibility

Participant inclusion criteria

Eligible patients included postmenopausal women at least 5 years of postmenopausal period, who either:
1. Never used HRT (Group 1: 128 patients) after menopause
2. Continuously used HRT (Group 2: 136 patients) for more 5 years from menopause

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Group 1: 128 patients, Group 2: 136 patients

Participant exclusion criteria

1. A history of any ocular injury or disorder
2. An infection, inflammation, surgery within the prior 6 months
3. Any uncontrolled systemic disease, or significant illness

Recruitment start date

01/06/2012

Recruitment end date

01/03/2014

Locations

Countries of recruitment

Korea, South

Trial participating centre

Bucheon St. Mary's Hospital
Bucheon
420-717
Korea, South

Sponsor information

Organisation

Bucheon St. Mary's Hospital (South Korea)

Sponsor details

c/o Prof. Eun Chul Kim
Department of Ophthalmology
Bucheon St. Mary's Hospital
327 Sosa-ro
Wonmi-gu
Gyeonggi-do
Bucheon
420-717
Korea
South

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Research Foundation of Korea (NRF) funded by the Ministry of Science, ICT & Future Planning (No. 2012R1A1A1038648) (South Korea)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Institute of Clinical Medicine Research of Bucheon St. Mary's Hospital, Research Fund, BCMC13LH03 (South Korea)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes