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

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03928665
• Other study ID #: ST.2012.001
• Status: Active, not recruiting
• Start date: October 1, 2012
• Est. completion date: October 1, 2027

Study information

• Verified date: November 2022
• Source: Wroclaw Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: October 1, 2027
• Est. primary completion date: December 1, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Glaucoma
• Ocular Hypertension
• Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
Poland	Department of Ophthalmology	Wroclaw

Sponsors (2)

Lead Sponsor	Collaborator
Wroclaw Medical University	Wroclaw University of Science and Technology

Country where clinical trial is conducted

Poland, 

References & Publications (2)

Chasens ER, Ratcliffe SJ, Weaver TE. Development of the FOSQ-10: a short version of the Functional Outcomes of Sleep Questionnaire. Sleep. 2009 Jul;32(7):915-9. — View Citation

Oddone F, Centofanti M, Rossetti L, Iester M, Fogagnolo P, Capris E, Manni G. Exploring the Heidelberg Retinal Tomograph 3 diagnostic accuracy across disc sizes and glaucoma stages: a multicenter study. Ophthalmology. 2008 Aug;115(8):1358-65, 1365.e1-3. doi: 10.1016/j.ophtha.2008.01.007. Epub 2008 Mar 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Influence of fogging lens on retinal sensitivity to given trigger (Goldman III) on standard automated and RareBit perimetry	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)	1 day
Other	Influence of tiredness on retinal sensitivity to given trigger (Goldman III) on standard automated and RareBit perimetry	Influence of different examinations that precedes visual field examination on the perimetry test results (MD and PSD, or MHR, MMR and area under 90%).	1 day
Other	Peripapillar and macular vessels density	Measured on the custom-derived protocol and manufacturer software macular and peripapillar vessels density - Angio OCT (OCTA)	5 years
Primary	Perimetry changes over the 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.	10 years
Primary	Flicker defined form perimetry changes over the 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.	10 years
Primary	RareBit perimetry changes over the 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.	10 years
Secondary	Functional Outcomes of Sleep Questionnaire	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.	10 years
Secondary	Epworth Sleepiness Scale	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).	10 years
Secondary	Pittsburgh Sleep Quality Index	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.	10 years
Secondary	Change in thickness of the retinal nerve fibre layer (RNFL)	A difference in thickness of the retinal nerve fibre layer during the observation time frame.	10 years
Secondary	Change in the optic nerve morphology - standard chart of HRT	A difference in morphology parameters given by HRT (additional information given in supplementary materials) during the observation time frame.	10 years
Secondary	AREDS 2008 Clinical Lens Opacity Grading Procedure	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.	10 years
Secondary	Macular changes in optical coherent tomography (OCT)	Evaluation of macular appearance based on the OCT scans. Any changes from normal appearance will be recorded and evaluated.	10 years
Secondary	Disc damage likelihood scale (DDLS)	Evaluation disc damage likelihood scale based on the fundus photographs (based on the visual scale given in additional documents)	10 years