Acetazolamide in X-linked Retinoschisis

The effect of Acetazolamide on visual acuity, retinal thickness and macular cyst size in patients with X-linked retinoschisis

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000476033

Acronym

Nil

Enrollment

Registered

2010-06-10

Start date

2010-06-21

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

X-linked retinoschisis is a genetic eye disorder characterised by abnormal splitting of the retina, resulting in a loss of vision. Currently there is no treatment available for X-linked retinoschisis. However, an improvement in sight has been reported following the use of topical and oral acetazolamide in people with X-linked retinoschisis. Hence, the objective of this study is to investigate whether oral acetazolamide improves the sight of people with X-linked retinoschisis.

Interventions

Oral acetazolamide 200mg twice a day >60kg or 125mg twice <60kg. Participants allocated to the acetazolamide/placebo study arm will receive acetazolamide first, followed by placebo, and vice versa in the placebo/acetazolamide. The duration of acetazolamide will be three months. The mode of administration is oral capsule. Cross over occurs at 3 months following first dose of treatment. Measurements at are done at 0, 3 and 6months. Hence no "wash-out" period is required.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

Inclusion criteria

- Patients with X-linked retinoschisis diagnosis and stable ocular fixation with no clinically significant media opacities. There will be no age restrictions

Exclusion criteria

- Hypersensitivity to sulphonamides and sulphonamide derivatives - Women who are pregnant - People in existing dependent or unequal relationships - People highly dependent on medical care - Aboriginal and/or Torres Striait Islander People - People who may be involved in illegal activity - People with an intellectual or mental impairment - People whose primary language is other than English. - A refractive error greater than ±6 diopters (D) sphere - Uveitis - Optic neuropathy - The presence of nystagmus or any other retinal diseases affecting the macula other than retinoschisis - A recent history (<6months) of intraocular surgery, and poor optical coherent tomography (OCT) image quality.

Outcome results