Refractive ErrorsNCT03655743
PRO Measure for Refractive Surgery IRAS Project Number 246072
An observational study of Refractive Errors and Satisfaction, run by Moorfields Eye Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The development and validation of a concise, practical, on-line, self-administered, self-archiving, and self-scoring PRO questionnaire for routine clinical use in refractive surgery is the primary study objective. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractive Errors, Satisfaction, Cornea
- What is being tested?
- LASIK, PRK, Phacoemulsification
- Type of treatment
- Medical device
- How many people
- 372 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 Aug 2018to 18 Mar 2020
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients who are planning are have had refractive surgery.
Who may be able to join
- Refractive Surgery
Who cannot join
- Participation denied.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Moorfields Eye Hospital NHS Foundation Trust, 162 City Road
London, EC1V 2PD
About this study
Official title: Development of a New Patient Reported Outcome (PRO) Measure for Refractive Surgery Patients as Part of the National Dataset in Refractive Surgery
The development and validation of a concise, practical, on-line, self-administered, self-archiving, and self-scoring PRO questionnaire for routine clinical use in refractive surgery is the primary study objective. Secondary objectives are to gather outcome data from patients before and after surgery in each of the following domains comprising key elements of vision related quality of life: spectacle dependence; quality of vision; eye comfort; freedom; emotional well-being; and overall satisfaction with the results of surgery. Patients undergoing refractive surgery at Moorfields Private Outpatient Clinic will be enrolled in the study in the validation phase.
Read the detailed description
Specific aims of the study The investigators aim to take a novel PRO questionnaire from the conceptual framing stage through a well-defined validation pathway including cognitive interviews, field data collection in the target population, and Rasch modification. Secondary aims are to take the modified instrument through prospective studies of repeatability and sensitivity to change. The investigators´ ultimate goal is to develop a concise, screen based, self-administered, self-archiving and self-scoring PRO instrument for use as part of the National Dataset in Refractive Surgery.
Study Design
Step 1. Conceptual framing and draft development Conceptual framing and draft development for the questionnaire is complete. This was based on a comprehensive literature review, patient and surgeon feedback during RCOphth Refractive Surgery Standards development consultation, and advice from a panel of expert collaborators.
The investigators began with a literature review of existing refractive error specific questionnaires, including the following: (1) National Eye Institute Refractive Quality of Life (NEI-RQL), (2) Refractive Status and Vision Profile (RSVP), (3) Quality of Life Impact of Refractive Correction (QIRC), (4) Quality of Vision (QoV), (5) Canadian Refractive Surgery Research Group Quality of Vision Questionnaire (QVQ), (6) PERK Study Questionnaire, (7) Multidimensional Quality of Life for Myopia (MQLM) Scale, (8) Myopia-Specific Quality of Life Questionnaire (MQLQ), (9) Subjective Vision Questionnaire (SVQ), (10) Refractive Error Quality of Life Scale (REQ-Thai), (11) The Freedom from Glasses Value Scale (FGVS), (12) Near Activity Visual Questionnaire (NAVQ), Catquest questionnaire (CatQuest 9SF), and ocular comfort index (OCI).
Those questionnaires have been identified as refractive error specific in a recent review article published in JRS. The ocular comfort index (OCI) addresses ocular surface irritation. Unlike previous instruments designed to measure eye comfort such as the widely used ocular surface disease index (OSDI), it is unidimensional and was developed using Rasch fitting.
According to FDA recommendations, a conceptual framework is helpful in guiding the development of a PRO instrument . Following these recommendations, the investigators first identified the aspects of PRO for refractive surgery to be measured. Each of these aspects or "domains" is measured by a set of items. The investigators identified and included the following subscales:
- Spectacle dependence
- Quality of vision
- Ocular comfort symptoms /Eye comfort (Eye comfort is used in the questionnaire)
- Freedom
- Looking and Feeling Well
- Overall satisfaction
Having defined the domains of interest, the next task was to reduce and adapt the pool of candidate questionnaire items. Winnowing refers to reducing the item pool to the smallest number of items, making sure that the domain of interest will still be adequately measured. DeWalt et al. stated that winnowing helps to accurately define and identify those item characteristics relevant to each domain. Items are deleted if they are considered to duplicate the information captured, or if they are deemed to be potentially confusing to respondents. The investigators focused preferentially on items from Rasch weighted instruments. The investigators also reviewed items within each domain attempting to ensure, with input from patients and experts, that the most relevant aspects of each domain are captured by the item sets in the draft instrument. The investigators intended to keep a set of non-redundant items that are consistent with the domain, universally understood, and relevant to a wide range of the adult population. Items were revised so they would be understood by the largest possible number of people. In addition, consistency was sought to the extent possible in wording, recall interval, and response options.
The investigators opted to use four response options based on a balance between parsimony and adequate sampling. Both the most widely used current instruments (QIRC and CatQuest), after Rasch modification in development, focus on four response option scales.
To make items more universally understood, slight modifications to item stems and/or response options from their original form were made in those cases where we believed simplification was necessary. All changes in wording were then tested versus original versions in cognitive interviews. Items that were too long or confusing were shortened.
Step 2. Cognitive interviews Cognitive interviews will be conducted to optimise face validity (comprehensibility) of items and response options. Forty participants will be recruited from the waiting rooms of the Refractive Surgery Service at Moorfields Private Eye Hospital (Consultant Bruce Allan MD). The sample should include 20 males and 20 females of different age and educational background (highest degree). A trained interviewer (Andreas Frings MD) will conduct all of the cognitive interviews. Participants will be asked to describe in their own words what each item is asking, and in some cases to compare different ways of asking the same question. These interviews will be helpful because subjects can directly provide input and suggestions on every item considered for inclusion. As a result of these interviews, items could be further simplified, some words could be deleted, some items could be reworded, and some parts of the stems could be added to response options for clarity. The revised survey will then be used for field testing.
Step 3. Field testing and item calibration After questionnaire refinement resulting from cognitive interviews, the investigators will gather completed questionnaire data from a representative cross-section of the target patient population for Rasch fitting. Step 2 is the major component of the validation study and is described in detail below.
- Conditions
- Refractive Errors, Satisfaction, Cornea, Lens Diseases
- Being tested
- LASIK, PRK, Phacoemulsification
- Medical subject headings
- Refractive Errors, Personal Satisfaction, Corneal Diseases, Lens Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LASIK, PRK, PhacoemulsificationDevice
Please see:
https://en.wikipedia.org/wiki/LASIK https://en.wikipedia.org/wiki/Photorefractive_keratectomy https://en.wikipedia.org/wiki/Phacoemulsification
| Study group | Role | What they receive |
|---|---|---|
| Patients after refractive surgery | Patients have had any type of corneal or lens refractive surgery. Receives: Device: LASIK, PRK, Phacoemulsification | |
| Patients before refractive surgery | Patients will have any type of corneal or lens refractive surgery. Receives: Device: LASIK, PRK, Phacoemulsification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective satisfaction with treatment and treatment results.
- Spectacle dependence: Grading: NEVER OCCASIONALLY SOME OF THE TIME MOST OF THE TIME
- Quality of vision : Grading: NO PROBLEM MILD MODERATE SEVERE
- Ocular comfort symptoms /Eye comfort: Grading: NO PROBLEM MILD MODERATE SEVERE
- Freedom: Grading: NO PROBLEM MILD MODERATE SEVERE
- Looking and Feeling Well: Grading but no definitions: NEVER OCCASIONALLY SOME OF THE TIME MOST OF THE TIME
- Overall satisfaction:
Grading:
VERY DISSATISFIED DISSATISFIED SATISFIED VERY SATISFIED
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start31 Aug 2018
- Primary completion29 Apr 2019
- Study completion18 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Refractive ErrorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 372 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03655743
- Sponsor's protocol ID
- ALLB1020
- Status last verified
- Apr 2022
- First submitted
- 10 Aug 2018
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Berry S, Mangione CM, Lindblad AS, McDonnell PJ. Development of the National Eye Institute refractive error correction quality of life questionnaire: focus groups. Ophthalmology. 2003;110:2285-2291 // Bland JM & Altman DG. Measuring agreement in method comparison studies. Stat Methods Med Res 1999; 8: 135-160 // Bottomley A, Jones D, Claassens L. Patient-reported outcomes: assessment and current perspectives of the guidelines of the Food and Drug Administration and the reflection paper of the European Medicines Agency. Eur J Cancer. 2009;45:347-53 // Bourque LB, Cosand BB, Drews C, Waring GO 3rd, Lynn M, Cartwright C. Reported satisfaction, fluctuation of vision, and glare among patients one year after surgery in the Prospective Evaluation of Radial Keratotomy (PERK) Study. Arch Ophthalmol. 1986;104:356-363 // Brunette I, Gresset J, Boivin J-F, Boisjoly H, Makni H. Function¬al outcome and satisfaction after photorefractive keratectomy: Part 1. Development and validation of a survey questionnaire. Ophthalmology. 2000;107:1783-1789 // Buckhurst PJ, Wolffsohn JS, Gupta N, Naroo SA, Davies LN, Shah S. Development of a questionnaire to assess the relative subjective benefits of presbyopia correction. J Cataract Refract Surg. 2012;38:74-79 // DeWalt DA, Rothrock N, Yount S, Stone AA; PROMIS Cooperative Group. Evaluation of item candidates: the PROMIS qualitative item review. Med Care. 2007;45:12-21 // Erickson DB, Stapleton F, Erickson P, du Toit R, Giannako¬poulos E, Holden B. Development and validation of a multi¬dimensional quality-of-life scale for myopia. Optom Vis Sci. 2004;81:70-81 // Finger RP, Fenwick E, Owsley C, Holz FG, Lamoureux EL. Visual functioning and quality of life under low luminance: evaluation of the German Low Luminance Questionnaire. Invest Ophthalmol Vis Sci. 2011;52:8241-9 // Fraenkel G, Comaish lF, Lawless MA, Kelly MR, Dunn SM, Byth K, Webber SK, Sutton GL, Rogers CM. Development of a questionnaire to assess subjective vision score in myopes seeking refractive surgery. J Refract Surg. 2004;20:10-9 // Gothwal VK, Reddy SP, Bharani S, Bagga DK, Sumalini R, Garudadri CS, Rao HL, Senthil S, Pathak-Ray V, Mandal AK. Impact of glaucoma on visual functioning in Indians. Invest Ophthalmol Vis Sci. 2012;53:6081-92 // Hays RD, Mangione CM, Ellwein L, Lindblad AS, Spritzer KL, McDonnell PJ. Psychometric properties of the National Eye Institute-Refractive Error Quality of Life instrument. Ophthalmology. 2003;110:2292-301 // Johnson ME, Murphy PJ. Measurement of ocular surface irritation on a linear interval scale with the ocular comfort index (OCI). Invest Ophth Vis Sci 2007;48:4451-8 // Kandel H, Khadka J, Lundström M, Goggin M, Pesudovs K. Questionnaires for Measuring Refractive Surgery Outcomes. J Refract Surg. 2017;33:416-424 // Khadka J, McAlinden C, Pesudovs K. Quality assessment of ophthalmic questionnaires: review and recommendations. Optometry and Vision Science 2013; 90: 720-744 // Lee J, Lee J, Park K, Cho W, Kim JY, Kang HY. Assessing the value of laser in situ keratomileusis by patient-reported outcomes using quality of life assessment. J Refract Surg. 2005;21:59-71 // Lévy P, Elies D, Dithmer O, Gil-Campos I, Benmedjahed K, Berdeaux, Arnould B. Development of a new subjective questionnaire: the Freedom from Glasses Value Scale (FGVS). J Refract Surg. 2010;26:438-46 // Lundström M, Pesudovs K. Catquest-9SF: patient outcomes questionnaire - nine-item short-form Rasch-scaled revision of the Catquest questionnaire. J Cat Refract Surg 2009;35:504-13 //
Lundström M, Pesudovs K. Questionnaires for measuring cataract surgery outcomes. J Cataract Refract Surg. 2011;37:945-59 // McAlinden C, Pesudovs K, Moore JE. The development of an in¬strument to measure quality of vision: the Quality of Vision (QoV) questionnaire. Invest Ophthalmol Vis Sci. 2010;51:5537-5545 // Mokkink LB, Terwee CB, Knol DL, Stratford PW, Alonso J, Patrick DL, Bouter LM, de Vet HC. The COSMIN checklist for evaluating the methodological quality of studies on measurement properties: a clarification of its content. BMC Med Res Methodol 2010;10:22 // Mokkink LB, Terwee CB, Patrick DL, Alonso J, Stratford PW, Knol DL, Bouter LM, de Vet HC. The COSMIN checklist for assessing the methodological quality of studies on measurement properties of health status measurement instruments: an international Delphi study. Qual Life Res. 2010;19:539-49 // Mullin PA, Lohr KN, Bresnahan BW, McNulty P. Applying cognitive design principles to formatting HRQOL instruments. Qual Life Res. 2000;9:13-27 // Pesudovs K, Garamendi E, Keeves JP, Elliott DB. The Activities of Daily Vision Scale for cataract surgery outcomes: re-evaluating validity with Rasch analysis. Invest Ophthalmol Vis Sci 2003;44: 2892-9 // Pesudovs K, Garamendi E, Elliott DB. The Quality of Life Impact of Refractive Correction (QIRC) Questionnaire: develop¬ment and validation. Optom Vis Sci. 2004;81:769-777 // Pesudovs K, Burr JM, Harley C, Elliott DB. The development, assessment, and selection of questionnaires. Optom Vis Sci. 2007;84:663-74 // Pesudovs K, Ratcliffe J, Lamoureux EL, Lundström M, Massof RW, Rubin GS. Measuring the patient's perspective. Optom Vis Sci. 2013;90:717-9 // Revicki DA; Regulatory Issues and Patient-Reported Outcomes Task Force for the International Society for Quality of Life Research. FDA draft guidance and health-outcomes research. Lancet. 2007;369:540-2 // Schein OD. The measurement of patient-reported outcomes of refractive surgery: the refractive status and vision profile. Trans Am Ophthalmol Soc. 2000;98:439-469 // Sukhawarn R, Wiratchai N, Tatsanavivat P, Pitiyanuwat S, Kanato M, Srivannaboon S, Guyatt GH. Development of a refractive error quality of life scale for Thai adults (the REQ-Thai). J Med Assoc Thai. 2011;94:978-84 // Vandenbroeck S, De Geest S, Zeyen T, Stalmans I, Dobbels F. Patient-reported outcomes (PRO's) in glaucoma: a systematic review. Eye (Lond). 2011;25:555-77 // Vitale S, Schein OD, Meinert CL, Steinberg EP. The refractive status and vision profile: a questionnaire to measure vision-related quality of life in persons with refractive error. Ophthalmology. 2000;107:1529-1539
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a New Patient Reported Outcome (PRO) Measure for Refractive Surgery Patients as Part of the National Dataset in Refractive Surgery
- ClinicalTrials.gov ID
- NCT03655743
- Acronym / sponsor ID
- ALLB1020
- Conditions
- Refractive Errors, Satisfaction, Cornea, Lens Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 372 participants (actual)
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation TrustUniversity, hospital or other
- Study start
- 31 Aug 2018 (actual)
- Primary completion
- 29 Apr 2019 (actual)
- Study completion
- 18 Mar 2020 (actual)
- First posted
- 31 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The development and validation of a concise, practical, on-line, self-administered, self-archiving, and self-scoring PRO questionnaire for routine clinical use in refractive surgery is the primary study objective. Secondary objectives are to gather outcome data from patients before and after surgery in each of the following domains comprising key elements of vision related quality of life: spectacle dependence; quality of vision; eye comfort; freedom; emotional well-being; and overall satisfaction with the results of surgery. Patients undergoing refractive surgery at Moorfields Private Outpatient Clinic will be enrolled in the study in the validation phase.
Detailed description
Specific aims of the study The investigators aim to take a novel PRO questionnaire from the conceptual framing stage through a well-defined validation pathway including cognitive interviews, field data collection in the target population, and Rasch modification. Secondary aims are to take the modified instrument through prospective studies of repeatability and sensitivity to change. The investigators´ ultimate goal is to develop a concise, screen based, self-administered, self-archiving and self-scoring PRO instrument for use as part of the National Dataset in Refractive Surgery.
Study Design
Step 1. Conceptual framing and draft development Conceptual framing and draft development for the questionnaire is complete. This was based on a comprehensive literature review, patient and surgeon feedback during RCOphth Refractive Surgery Standards development consultation, and advice from a panel of expert collaborators.
The investigators began with a literature review of existing refractive error specific questionnaires, including the following: (1) National Eye Institute Refractive Quality of Life (NEI-RQL), (2) Refractive Status and Vision Profile (RSVP), (3) Quality of Life Impact of Refractive Correction (QIRC), (4) Quality of Vision (QoV), (5) Canadian Refractive Surgery Research Group Quality of Vision Questionnaire (QVQ), (6) PERK Study Questionnaire, (7) Multidimensional Quality of Life for Myopia (MQLM) Scale, (8) Myopia-Specific Quality of Life Questionnaire (MQLQ), (9) Subjective Vision Questionnaire (SVQ), (10) Refractive Error Quality of Life Scale (REQ-Thai), (11) The Freedom from Glasses Value Scale (FGVS), (12) Near Activity Visual Questionnaire (NAVQ), Catquest questionnaire (CatQuest 9SF), and ocular comfort index (OCI).
Those questionnaires have been identified as refractive error specific in a recent review article published in JRS. The ocular comfort index (OCI) addresses ocular surface irritation. Unlike previous instruments designed to measure eye comfort such as the widely used ocular surface disease index (OSDI), it is unidimensional and was developed using Rasch fitting.
According to FDA recommendations, a conceptual framework is helpful in guiding the development of a PRO instrument . Following these recommendations, the investigators first identified the aspects of PRO for refractive surgery to be measured. Each of these aspects or "domains" is measured by a set of items. The investigators identified and included the following subscales:
- Spectacle dependence
- Quality of vision
- Ocular comfort symptoms /Eye comfort (Eye comfort is used in the questionnaire)
- Freedom
- Looking and Feeling Well
- Overall satisfaction
Having defined the domains of interest, the next task was to reduce and adapt the pool of candidate questionnaire items. Winnowing refers to reducing the item pool to the smallest number of items, making sure that the domain of interest will still be adequately measured. DeWalt et al. stated that winnowing helps to accurately define and identify those item characteristics relevant to each domain. Items are deleted if they are considered to duplicate the information captured, or if they are deemed to be potentially confusing to respondents. The investigators focused preferentially on items from Rasch weighted instruments. The investigators also reviewed items within each domain attempting to ensure, with input from patients and experts, that the most relevant aspects of each domain are captured by the item sets in the draft instrument. The investigators intended to keep a set of non-redundant items that are consistent with the domain, universally understood, and relevant to a wide range of the adult population. Items were revised so they would be understood by the largest possible number of people. In addition, consistency was sought to the extent possible in wording, recall interval, and response options.
The investigators opted to use four response options based on a balance between parsimony and adequate sampling. Both the most widely used current instruments (QIRC and CatQuest), after Rasch modification in development, focus on four response option scales.
To make items more universally understood, slight modifications to item stems and/or response options from their original form were made in those cases where we believed simplification was necessary. All changes in wording were then tested versus original versions in cognitive interviews. Items that were too long or confusing were shortened.
Step 2. Cognitive interviews Cognitive interviews will be conducted to optimise face validity (comprehensibility) of items and response options. Forty participants will be recruited from the waiting rooms of the Refractive Surgery Service at Moorfields Private Eye Hospital (Consultant Bruce Allan MD). The sample should include 20 males and 20 females of different age and educational background (highest degree). A trained interviewer (Andreas Frings MD) will conduct all of the cognitive interviews. Participants will be asked to describe in their own words what each item is asking, and in some cases to compare different ways of asking the same question. These interviews will be helpful because subjects can directly provide input and suggestions on every item considered for inclusion. As a result of these interviews, items could be further simplified, some words could be deleted, some items could be reworded, and some parts of the stems could be added to response options for clarity. The revised survey will then be used for field testing.
Step 3. Field testing and item calibration After questionnaire refinement resulting from cognitive interviews, the investigators will gather completed questionnaire data from a representative cross-section of the target patient population for Rasch fitting. Step 2 is the major component of the validation study and is described in detail below.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients after refractive surgery | – | Device: LASIK, PRK, PhacoemulsificationPatients have had any type of corneal or lens refractive surgery. |
| Patients before refractive surgery | – | Device: LASIK, PRK, PhacoemulsificationPatients will have any type of corneal or lens refractive surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who are planning are have had refractive surgery.
Key inclusion criteria (1 listed)
- Refractive Surgery
Key exclusion criteria (1 listed)
- Participation denied.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LASIK, PRK, PhacoemulsificationPlease see: https://en.wikipedia.org/wiki/LASIK https://en.wikipedia.org/wiki/Photorefractive_keratectomy https://en.wikipedia.org/wiki/Phacoemulsification | Device | Patients after refractive surgery, Patients before refractive surgery |
Primary outcome
Subjective satisfaction with treatment and treatment results.
Time frame: 12 months
1. Spectacle dependence: Grading: NEVER OCCASIONALLY SOME OF THE TIME MOST OF THE TIME 2. Quality of vision : Grading: NO PROBLEM MILD MODERATE SEVERE 3. Ocular comfort symptoms /Eye comfort: Grading: NO PROBLEM MILD MODERATE SEVERE 4. Freedom: Grading: NO PROBLEM MILD MODERATE SEVERE 5. Looking and Feeling Well: Grading but no definitions: NEVER OCCASIONALLY SOME OF THE TIME MOST OF THE TIME 6. Overall satisfaction: Grading: VERY DISSATISFIED DISSATISFIED SATISFIED VERY SATISFIED
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- BackgroundBerry S, Mangione CM, Lindblad AS, McDonnell PJ. Development of the National Eye Institute refractive error correction quality of life questionnaire: focus groups. Ophthalmology. 2003;110:2285-2291 // Bland JM & Altman DG. Measuring agreement in method comparison studies. Stat Methods Med Res 1999; 8: 135-160 // Bottomley A, Jones D, Claassens L. Patient-reported outcomes: assessment and current perspectives of the guidelines of the Food and Drug Administration and the reflection paper of the European Medicines Agency. Eur J Cancer. 2009;45:347-53 // Bourque LB, Cosand BB, Drews C, Waring GO 3rd, Lynn M, Cartwright C. Reported satisfaction, fluctuation of vision, and glare among patients one year after surgery in the Prospective Evaluation of Radial Keratotomy (PERK) Study. Arch Ophthalmol. 1986;104:356-363 // Brunette I, Gresset J, Boivin J-F, Boisjoly H, Makni H. Function¬al outcome and satisfaction after photorefractive keratectomy: Part 1. Development and validation of a survey questionnaire. Ophthalmology. 2000;107:1783-1789 // Buckhurst PJ, Wolffsohn JS, Gupta N, Naroo SA, Davies LN, Shah S. Development of a questionnaire to assess the relative subjective benefits of presbyopia correction. J Cataract Refract Surg. 2012;38:74-79 // DeWalt DA, Rothrock N, Yount S, Stone AA; PROMIS Cooperative Group. Evaluation of item candidates: the PROMIS qualitative item review. Med Care. 2007;45:12-21 // Erickson DB, Stapleton F, Erickson P, du Toit R, Giannako¬poulos E, Holden B. Development and validation of a multi¬dimensional quality-of-life scale for myopia. Optom Vis Sci. 2004;81:70-81 // Finger RP, Fenwick E, Owsley C, Holz FG, Lamoureux EL. Visual functioning and quality of life under low luminance: evaluation of the German Low Luminance Questionnaire. Invest Ophthalmol Vis Sci. 2011;52:8241-9 // Fraenkel G, Comaish lF, Lawless MA, Kelly MR, Dunn SM, Byth K, Webber SK, Sutton GL, Rogers CM. Development of a questionnaire to assess subjective vision score in myopes seeking refractive surgery. J Refract Surg. 2004;20:10-9 // Gothwal VK, Reddy SP, Bharani S, Bagga DK, Sumalini R, Garudadri CS, Rao HL, Senthil S, Pathak-Ray V, Mandal AK. Impact of glaucoma on visual functioning in Indians. Invest Ophthalmol Vis Sci. 2012;53:6081-92 // Hays RD, Mangione CM, Ellwein L, Lindblad AS, Spritzer KL, McDonnell PJ. Psychometric properties of the National Eye Institute-Refractive Error Quality of Life instrument. Ophthalmology. 2003;110:2292-301 // Johnson ME, Murphy PJ. Measurement of ocular surface irritation on a linear interval scale with the ocular comfort index (OCI). Invest Ophth Vis Sci 2007;48:4451-8 // Kandel H, Khadka J, Lundström M, Goggin M, Pesudovs K. Questionnaires for Measuring Refractive Surgery Outcomes. J Refract Surg. 2017;33:416-424 // Khadka J, McAlinden C, Pesudovs K. Quality assessment of ophthalmic questionnaires: review and recommendations. Optometry and Vision Science 2013; 90: 720-744 // Lee J, Lee J, Park K, Cho W, Kim JY, Kang HY. Assessing the value of laser in situ keratomileusis by patient-reported outcomes using quality of life assessment. J Refract Surg. 2005;21:59-71 // Lévy P, Elies D, Dithmer O, Gil-Campos I, Benmedjahed K, Berdeaux, Arnould B. Development of a new subjective questionnaire: the Freedom from Glasses Value Scale (FGVS). J Refract Surg. 2010;26:438-46 // Lundström M, Pesudovs K. Catquest-9SF: patient outcomes questionnaire - nine-item short-form Rasch-scaled revision of the Catquest questionnaire. J Cat Refract Surg 2009;35:504-13 //
- BackgroundLundström M, Pesudovs K. Questionnaires for measuring cataract surgery outcomes. J Cataract Refract Surg. 2011;37:945-59 // McAlinden C, Pesudovs K, Moore JE. The development of an in¬strument to measure quality of vision: the Quality of Vision (QoV) questionnaire. Invest Ophthalmol Vis Sci. 2010;51:5537-5545 // Mokkink LB, Terwee CB, Knol DL, Stratford PW, Alonso J, Patrick DL, Bouter LM, de Vet HC. The COSMIN checklist for evaluating the methodological quality of studies on measurement properties: a clarification of its content. BMC Med Res Methodol 2010;10:22 // Mokkink LB, Terwee CB, Patrick DL, Alonso J, Stratford PW, Knol DL, Bouter LM, de Vet HC. The COSMIN checklist for assessing the methodological quality of studies on measurement properties of health status measurement instruments: an international Delphi study. Qual Life Res. 2010;19:539-49 // Mullin PA, Lohr KN, Bresnahan BW, McNulty P. Applying cognitive design principles to formatting HRQOL instruments. Qual Life Res. 2000;9:13-27 // Pesudovs K, Garamendi E, Keeves JP, Elliott DB. The Activities of Daily Vision Scale for cataract surgery outcomes: re-evaluating validity with Rasch analysis. Invest Ophthalmol Vis Sci 2003;44: 2892-9 // Pesudovs K, Garamendi E, Elliott DB. The Quality of Life Impact of Refractive Correction (QIRC) Questionnaire: develop¬ment and validation. Optom Vis Sci. 2004;81:769-777 // Pesudovs K, Burr JM, Harley C, Elliott DB. The development, assessment, and selection of questionnaires. Optom Vis Sci. 2007;84:663-74 // Pesudovs K, Ratcliffe J, Lamoureux EL, Lundström M, Massof RW, Rubin GS. Measuring the patient's perspective. Optom Vis Sci. 2013;90:717-9 // Revicki DA; Regulatory Issues and Patient-Reported Outcomes Task Force for the International Society for Quality of Life Research. FDA draft guidance and health-outcomes research. Lancet. 2007;369:540-2 // Schein OD. The measurement of patient-reported outcomes of refractive surgery: the refractive status and vision profile. Trans Am Ophthalmol Soc. 2000;98:439-469 // Sukhawarn R, Wiratchai N, Tatsanavivat P, Pitiyanuwat S, Kanato M, Srivannaboon S, Guyatt GH. Development of a refractive error quality of life scale for Thai adults (the REQ-Thai). J Med Assoc Thai. 2011;94:978-84 // Vandenbroeck S, De Geest S, Zeyen T, Stalmans I, Dobbels F. Patient-reported outcomes (PRO's) in glaucoma: a systematic review. Eye (Lond). 2011;25:555-77 // Vitale S, Schein OD, Meinert CL, Steinberg EP. The refractive status and vision profile: a questionnaire to measure vision-related quality of life in persons with refractive error. Ophthalmology. 2000;107:1529-1539
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Refractive Errors and Satisfaction, run by Moorfields Eye Hospital NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective satisfaction with treatment and treatment results. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03655743, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2022.