Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT03928665

Long-term Observation of Ophthalmic Changes in Patients With Obstructive Sleep Apnea

The ophthalmic changes during long-lasting sleep apnea are lacking in description and assessment. The investigators intend to observe patients for a long time and observe if the changes in eye tissues are progressing over the years in easily recognizable patterns.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Ophthalmology

Wroclaw, 50-556, Poland

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • newly diagnosed obstructive sleep apnea indicated for positive airway pressure therapy,
  • ongoing treatment of sleep apnea with positive airway pressure therapy,
  • patients older than 18 years,
  • signed inform consent

Exclusion criteria

  • pregnant and breastfeeding persons

Treatment and study plan

Primary outcomes

  1. Perimetry changes over the years

    Time frame: 10 years

    Changes in retinal sensitivity (measured in decibels/ dB) during observation time measured by standard automated perimetry. The manner of presentation of overall descriptors auch as: mean deviation (MD; dB) and pattern standard deviation (PSD; dB) will be recorded.

  2. Flicker defined form perimetry changes over the years

    Time frame: 10 years

    Changes in retinal sensitivity (measured in decibels/ dB) during observation time measured by standard automated perimetry with flicker defined form signal. The manner of presentation of overall descriptors auch as: mean deviation (MD; dB) and pattern standard deviation (PSD; dB) will be recorded.

  3. RareBit perimetry changes over the years

    Time frame: 10 years

    Changes in Changes in retinal sensitivity (measured in percentage of all presented excitors/ %) during observation time measured by RareBit signal perimetry. The manner of presentation of overall descriptors auch as: mean hit rate (MHR; %), area under 90% (%) and sectorial mean miss rate (MMR; %) will be recorded.

Secondary outcomes

  1. Functional Outcomes of Sleep Questionnaire

    Time frame: 10 years

    Quality assessed with the Functional Outcomes of Sleep Questionnaire (FOSQ) comparing the score at baseline with during 10 years of observation. The questionnaire are composed of 30 questions that can be answered from 1 to 4 points (where 1 means extreme difficulty of doing an activity and 4 - no difficulties). Five subscales are given such as: General Productivity (8 questions -1 - 4, 8 - 11), Social Outcome (2 questions - 12, 13), Activity Level (9 questions - 5, 14 - 16, 22 - 26), Vigilance (7 questions - 6, 7, 17 - 21), Intimate Relationships and Sexual Activity (4 questions - 27 - 30). To obtain a Total Score: Calculate the mean of the subscale scores and multiply that mean by the number of subscales for which there is a score. The potential range of scores for the Total Score is 5 - 20.

  2. Epworth Sleepiness Scale

    Time frame: 10 years

    Quality assessed with the Epworth Sleepiness Scale comparing the score at baseline with during 10 years of observation. The questionnaire are composed of 8 questions describing activities during which patient can feel sleepy, each scored from 0 (zero probability to falling asleep) to 3 (very likely that patient will fall asleep).

  3. Pittsburgh Sleep Quality Index

    Time frame: 10 years

    Quality assessed with the Pittsburgh Sleep Quality Index comparing the score at baseline with during 10 years of observation. The questionnaire are composed of 10 questions composed in seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.

  4. Change in thickness of the retinal nerve fibre layer (RNFL)

    Time frame: 10 years

    A difference in thickness of the retinal nerve fibre layer during the observation time frame.

  5. Change in the optic nerve morphology - standard chart of HRT

    Time frame: 10 years

    A difference in morphology parameters given by HRT (additional information given in supplementary materials) during the observation time frame.

  6. AREDS 2008 Clinical Lens Opacity Grading Procedure

    Time frame: 10 years

    Using AREDS system for classifying cataracts from photographs: AREDS Report No. 4 the lens opacity will be graded. The change in grading during the observation time frame.

  7. Macular changes in optical coherent tomography (OCT)

    Time frame: 10 years

    Evaluation of macular appearance based on the OCT scans. Any changes from normal appearance will be recorded and evaluated.

  8. Disc damage likelihood scale (DDLS)

    Time frame: 10 years

    Evaluation disc damage likelihood scale based on the fundus photographs (based on the visual scale given in additional documents)

Other outcomes

  1. Influence of fogging lens on retinal sensitivity to given trigger (Goldman III) on standard automated and RareBit perimetry

    Time frame: 1 day

    A fogging lens will be applied (a modified by the author protocol of fogging - increasing of +0.5D lens to obtain the reduction in logMAR visual acuity by 0.2 from best-corrected visual acuity/ BCVA)

  2. Influence of tiredness on retinal sensitivity to given trigger (Goldman III) on standard automated and RareBit perimetry

    Time frame: 1 day

    Influence of different examinations that precedes visual field examination on the perimetry test results (MD and PSD, or MHR, MMR and area under 90%).

  3. Peripapillar and macular vessels density

    Time frame: 5 years

    Measured on the custom-derived protocol and manufacturer software macular and peripapillar vessels density - Angio OCT (OCTA)

Sponsors and collaborators

Lead sponsor

Wroclaw Medical University

Other

Collaborators

  • Wrocław University of Science and Technology

Registry information

Important dates

Study start
2012
Primary completion
2022
Study completion
2027
First posted
Apr 26, 2019
Registry last updated
Nov 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.