Therapeutic applications of soft contact lenses in severe dry eye with chronic graft-versus-host disease

ISRCTN	ISRCTN05106737
DOI	https://doi.org/10.1186/ISRCTN05106737
Secondary identifying numbers	001

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Junko Ogawa
Scientific

Shinanomachi 35 Shinjuku ku
Keio Univ Sch Med
Dept Ophthalmology
Tokyo
160-8582
Japan

Email	junoga1102@yahoo.co.jp

Study design	Retrospective, consisting of chart review of GVHD patients who received therapeutic contact lenses wear. Please note that chart reviews started in September 1, 2006 and will be finalised by spring next year.
Primary study design	Observational
Secondary study design	Single-centre
Study setting(s)	Hospital
Study type	Screening
Scientific title	Therapeutic applications of soft contact lenses in severe dry eye with chronic graft-versus-host disease
Study objectives	Bandage contact lenses have favourable effects on the occular surface disease status in severe dry eye patients with chronic Graft-Versus-Host Disease (cGVHD).
Ethics approval(s)	US Food and Drug Administration (FDA) approved contact lens material used for the study. Therapeutic contact lenses are not regarded as medical devices in Japan. According to our regulations, when contact lenses are deemed essential for therapeutic purposes by an ophthalmologist, permission from the university or hospital is not required.
Health condition(s) or problem(s) studied	Chronic graft versus host disease
Intervention	Silicone hydrogel Contact Lens use. Patients wore contact lenses continuously and replaced their contact lenses for every week to once in four weeks. Only patients with more than six months of follow up were included.
Intervention type	Other
Primary outcome measure	Pain relief
Secondary outcome measures	Vital staining score
Overall study start date	01/09/2006
Completion date	30/04/2007

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	10 patients
Total final enrolment	7
Key inclusion criteria	1. Severe cGVHD dry eye subjects with fibrotic lid changes and trichiasis refractory to treatment with non-preserved artificial tears 2. Autologous serum eye drops 3. Bilateral punctal occlusion
Key exclusion criteria	1. Mild cGVHD patients 2. cGVHD
Date of first enrolment	01/09/2006
Date of final enrolment	30/04/2007

Shinanomachi 35 Shinjuku ku

Tokyo
160-8582
Japan

Ciba Vision (Japan)
Industry

Tennoz Central Tower 13
2-2-24 Higashi Shinagawa
Tokyo
140-0002
Japan

Other

Contact lenses were donated by CIBA vision. Costs incurred by vital staining, and

No information available

slit lamp examinations were covered by social insurance.

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Abstract results	results presented at ARVO	01/05/2007	14/01/2021	No	No

14/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.