PRO Measure for Refractive Surgery IRAS Project Number 246072

NCT03655743 | Completed

• 1 other identifier: ALLB1020
• Study Type: observational
• Target: 372
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Refractive Errors; Satisfaction; Cornea; Lens Diseases

Outcome Measures

Primary Outcomes (1)

• Subjective satisfaction with treatment and treatment results.

  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

  12 months

Study Arms (2)

Patients after refractive surgery

Patients have had any type of corneal or lens refractive surgery.

Device: LASIK, PRK, Phacoemulsification

Patients before refractive surgery

Patients will have any type of corneal or lens refractive surgery.

Device: LASIK, PRK, Phacoemulsification

Interventions

LASIK, PRK, Phacoemulsification DEVICE

Please see: https://en.wikipedia.org/wiki/LASIK https://en.wikipedia.org/wiki/Photorefractive\_keratectomy https://en.wikipedia.org/wiki/Phacoemulsification

Patients after refractive surgery; Patients before refractive surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are planning are have had refractive surgery.

You may qualify if:

• Refractive Surgery

You may not qualify if:

• Participation denied.

Sponsors & Collaborators

• Moorfields Eye Hospital NHS Foundation Trust: lead

Study Sites (1)

Moorfields Eye Hospital NHS Foundation Trust, 162 City Road

London, EC1V 2PD, United Kingdom

Location

Related Publications (2)

• 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 //

  BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Refractive Errors; Personal Satisfaction; Corneal Diseases; Lens Diseases

Interventions

Keratomileusis, Laser In Situ; Photorefractive Keratectomy; Phacoemulsification

Condition Hierarchy (Ancestors)

Eye Diseases; Behavior

Intervention Hierarchy (Ancestors)

Corneal Surgery, Laser; Laser Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Keratectomy; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Cataract Extraction; Ultrasonic Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2018
• First Posted: August 31, 2018
• Study Start: August 31, 2018
• Primary Completion: April 29, 2019
• Study Completion: March 18, 2020
• Last Updated: April 12, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)