Department of Ophthalmology
Wroclaw, 50-556, Poland
NCT Number: NCT03928665
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.
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Observational
Wroclaw, 50-556, Poland
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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).
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.
Time frame: 10 years
A difference in thickness of the retinal nerve fibre layer during the observation time frame.
Time frame: 10 years
A difference in morphology parameters given by HRT (additional information given in supplementary materials) during the observation time frame.
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.
Time frame: 10 years
Evaluation of macular appearance based on the OCT scans. Any changes from normal appearance will be recorded and evaluated.
Time frame: 10 years
Evaluation disc damage likelihood scale based on the fundus photographs (based on the visual scale given in additional documents)
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)
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%).
Time frame: 5 years
Measured on the custom-derived protocol and manufacturer software macular and peripapillar vessels density - Angio OCT (OCTA)
Wroclaw Medical University
Other
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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.
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