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The effect of transsphenoidal pituitary adenomectomy on macular ganglion cell thickness, post-illumination pupil response, and sleep-wake rhythm

The effect of transsphenoidal pituitary adenomectomy on macular ganglion cell thickness, post-illumination pupil response, and sleep-wake rhythm - PAMPUS

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON55354
Enrollment
16
Registered
2018-09-06
Start date
2019-05-29
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

pituitary adenoma pituitary tumor

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • 18 years or older • Diagnosis of a pituitary adenoma with optic chiasm compression • Scheduled for elective transsphenoidal adenomectomy (i.e. not in an emergency setting)

Exclusion criteria

Exclusion criteria: • Ocular pathology, other than compressive optic neuropathy, that could influence SD-OCT or pupillometry measurements • Previous intra-ocular surgery • Previous pituitary surgery • Previous radiation in the pituitary area • Diabetes mellitus • Other comorbidity or medication use that could interfere with the study procedures • Inability to give informed consent

Design outcomes

Primary

MeasureTime frame
The main study parameters are the preoperative and postoperative macular ganglion cell-inner plexiform layer (GCIPL) thickness and PIPR measurements.

Secondary

MeasureTime frame
• Actigraphy parameters concerning circadian rhythm: interdaily stability, intradaily variability and amplitude • Preoperative and postoperative peripapillary retinal nerve fiber layer (RNFL) thickness • Subjective sleep parameters through questionnaires

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)