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dgGaP phs000001.v3.p1 NEI Age-Related Eye Disease Study (AREDS) - pht000370.v2.p1

- 10/12/22 - 19 forms, 1 itemgroup, 12 items, 1 language
Itemgroup: pht000370.v2.p1
https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000001.v3.p1 The Age-Related Eye Disease Study (AREDS) was initially designed as a long-term multi-center, prospective study of the clinical course of age-related macular degeneration (AMD) and age-related cataract. In addition to collecting natural history data, AREDS included a clinical trial of high-dose vitamin and mineral supplements for AMD and a clinical trial of high-dose vitamin supplements for cataract. AREDS participants were 55 to 80 years of age at enrollment and had to be free of any illness or condition that would make long-term follow-up or compliance with study medications unlikely or difficult. On the basis of fundus photographs graded by a central reading center, best-corrected visual acuity and ophthalmologic evaluations, 4,757 participants were enrolled in one of several AMD categories, including persons with no AMD. The clinical trials for AMD and cataract were conducted concurrently. AREDS participants were followed on the clinical trials for a median time of 6.5 years. Subsequent to the conclusion of the clinical trials, participants were followed for an additional 5 years and natural history data were collected. The AREDS research design is detailed in AREDS Report 1. AREDS Report 8 contains the mainline results from the AMD trial; AREDS Report 9 contains the results of the cataract trial. Blood samples were also collected from 3,700+ AREDS participants for genetic research. Genetic samples from 600 AREDS participants (200 controls, 200 Neovascular AMD cases, and 200 Geographic Atrophy cases) were selected using data available in March 2005 and then were evaluated with a genome-wide scan. These data, as well as selected phenotypic data, were made available in the dbGaP. DNA from AREDS participants, which is currently being stored in the AREDS Genetic Repository, is available for research purposes. However, not all of the 3,700+ AREDS participants who submitted a blood sample currently have DNA available. In addition to including the data from the genome-wide scan on the 600 original samples, this second version of the AREDS dbGaP database provides a comprehensive set of data tables with extensive clinical information collected for the 4,757 participants who participated in AREDS. The tables include information collected at enrollment/baseline, during study follow-up, fundus and lens pathology, nutritional estimates, quality of life measures and measures of morbidity and mortality. In November 2010, over 72,000 high quality fundus and lens photographs from 595 AREDS participants (of the original 600 selected for the genome-wide scan) were made available in the AREDS dbGaP. In addition to the genome-wide scan data, the fundus and lens grading data for these participants are also available in the AREDS dbGaP. Details about the ocular photographs that are available are found here. In January 2012, a measure of daily sunlight exposure was added in a separate "sunlight" table. Furthermore, the "followup" table has been revised. The visual acuity for the right eye was inadvertently missing at odd-numbered visits (01, 03, 05, etc.). This data is now part of the table. It is hoped that this resource will better help researchers understand two important diseases that affect an aging population. These data may be applied to examination and inference on genetic and genetic-environmental bases for age-related diseases of public health significance and may also help elucidate the clinical course of both conditions, generate hypotheses, and aid in the design of clinical trials of preventive interventions. *Definitions of Final AMD Phenotype Categories* Please see phd001138.1 for a detailed description of how AREDS participants' final AMD phenotype was categorized. *User's Guide for AREDS Phenotype Data* A detailed User's Guide for the AREDS phenotype data is available. This *User's Guide* is meant to be a comprehensive document which explains the complexities of the AREDS data. *It is recommended that all researchers using AREDS phenotype data make use of this User's Guide*.

pht000371.v2.p1

1 itemgroup 25 items

pht000001.v2.p1

1 itemgroup 142 items

pht000372.v2.p1

1 itemgroup 56 items

pht000379.v2.p1

1 itemgroup 21 items

pht000380.v2.p1

1 itemgroup 7 items

pht000381.v2.p1

1 itemgroup 44 items

ICHOM Cataracts - Pre- and intraoperative Clinical Form

- 9/20/21 - 1 form, 8 itemgroups, 33 items, 1 language
Itemgroups: Administrative Data, Demographic factors, Baseline visual status, Ocular Comorbidities, Prior ophthalmic interventions, Technical Factors, Treatment Variables, Intra-operative Complications
CATARACTS DATA COLLECTION Version 2.0.1 Revised: March 8th, 2017 International Consortium for Health Outcomes Measurement (ICHOM), Source: http://www.ichom.org/ Notice: This work was conducted using resources from ICHOM, the International Consortium for Health Outcomes Measurement (www.ICHOM.org). The content is solely the responsibility of the authors and does not necessarily represent the official views of ICHOM. Conditions: Symptomatic Cataract | Asymptomatic Cataract Treatment Approaches: Phacoemulsification | Sutured Extracapsular Cataract Extraction | Sutureless Extracapsular Cataract Extraction | Intracapsular Cataract Extraction Scores: Catquest-9SF - The Catquest-9SF is free for all health care organizations, and a license is not needed for use. by Mats Lundström et al. This ODM-file contains the pre-operative and intra-operative clinical Form. The items are to be filled in with clinical or administrative data, collected pre- or intraoperatively. Publication: Mahmud I, Kelley T, Stowell C, et al. A Proposed Minimum Standard Set of Outcome Measures for Cataract Surgery. JAMA Ophthalmol. 2015;133(11):1247–1252. doi:10.1001/jamaophthalmol.2015.2810 For this version of the standard set, semantic annotation with UMLS CUIs has been added.

GSK Eltrombopag Thrombocytopenia, Clinical Study ID: 105122 - Ocular History and Risk Factors

- 12/12/20 - 1 form, 3 itemgroups, 17 items, 1 language
Itemgroups: Administrative Data, ocular history and risk factors, cataract risk factors
The primary objective of this study was to demonstrate bioequivalence between eltrombopag oral film-coated tablets manufactured at Research and Development (R&D) and Commercial sites. The subject participants each went through two dosing periods (Period 1 and Period 2), during each of which they received a single dose of eltrombopag. The dosing periods were separated by a washout of at least 10 days. For each period, subjects had to perform a visit on the day before and one on the day of the administration of the drug. Furthermore, the protocol-defined visits included a screening visit, a follow-up visit, a logs and repeats visit, a PGx visit and a visit for the common CRF. Study ID: 105122 Clinical Study ID: 105122 Study Title: Phase I Bioequivalence Study for SB 497115 GR Phase II and Phase III Tablets Sponsor: GlaxoSmithKline Phase: phase 1 Study Recruitment Status: Completed Generic Name: Eltrombopag Study Indication: Thrombocytopenia This form has to be filled out at the Screening Visit.

CATQUEST 9SF

- 5/28/20 - 1 form, 3 itemgroups, 21 items, 6 languages
Itemgroups: Administrative Data, Questionnaire Number, Questionnaire
9 Question Short Form of CATQUEST: questionnaire for use in cataract surgery care To be used prior to and 3 months after cataract surgery. Forms used for ODM-files available for download from http://www.eurequo.org/category/downloads/catquest . With Permission from Mats Lundström (free to use, with no license demands). Publications: original Swedish (long) Version: Lundström M, Stenevi U, Thorburn W, Roos P. Catquest questionnaire for use in cataract surgery care: assessment of surgical outcomes. J Cataract Refract Surg. 1998 Jul;24(7):968-74. Swedish Short Form: Lundström M, Pesudovs K. Catquest-9SF patient outcomes questionnaire: nine-item short-form Rasch-scaled revision of the Catquest questionnaire. J Cataract Refract Surg. 2009 Mar;35(3):504-13. doi: 10.1016/j.jcrs.2008.11.038. English Translation (Australia): Gothwal VK1, Wright TA, Lamoureux EL, Lundström M, Pesudovs K. Catquest questionnaire: re-validation in an Australian cataract population. Clin Exp Ophthalmol. 2009 Nov;37(8):785-94. doi: 10.1111/j.1442-9071.2009.02133.x. German Translation: K. Gerstmeyer, A. Harrer, N. Hirnschall, K. Pesudovs, M. Lundstrom, O. Findl: Validierung der deutschen Version des schwedischen Catquest-9SF-Fragebogens. 2012, DGII Jahresband 2012, p. 214-222 Italian Translation: Skiadaresi E, Ravalico G, Polizzi S, Lundström M, González-Andrades M, McAlinden C. The Italian Catquest-9SF cataract questionnaire: translation, validation and application. Eye Vis (Lond). 2016 Apr 28;3:12. doi: 10.1186/s40662-016-0043-9. eCollection 2016. Spanish Translation: Lundström M, Llovet F, Llovet A, Martinez Del Pozo M, Mompean B, González JV, Pesudovs K. Validation of the Spanish Catquest-9SF in patients with a monofocal or trifocal intraocular lens. J Cataract Refract Surg. 2016 Dec;42(12):1791-1796. doi: 10.1016/j.jcrs.2016.10.011. Dutch Tranlsation (to be added): Visser MS, Dieleman M, Klijn S, Timman R, Lundström M, Busschbach JJ, Reus NJ. Validation, test-retest reliability and norm scores for the Dutch Catquest-9SF. Acta Ophthalmol. 2017 May;95(3):312-319. doi: 10.1111/aos.13287. Epub 2016 Oct 24.

ICHOM Cataracts - Patient-Reported Visual Function (pre- and post-operative)

- 4/30/20 - 1 form, 2 itemgroups, 11 items, 1 language
Itemgroups: Administrative Data, Patient-reported visual function
CATARACTS DATA COLLECTION Version 2.0.1 Revised: March 8th, 2017, International Consortium for Health Outcomes Measurement (ICHOM), Source: http://www.ichom.org/ Notice: This work was conducted using resources from ICHOM, the International Consortium for Health Outcomes Measurement (www.ICHOM.org). The content is solely the responsibility of the authors and does not necessarily represent the official views of ICHOM. Conditions: Symptomatic Cataract | Asymptomatic Cataract Treatment Approaches: Phacoemulsification | Sutured Extracapsular Cataract Extraction | Sutureless Extracapsular Cataract Extraction | Intracapsular Cataract Extraction Scores: Catquest-9SF - The Catquest-9SF is free for all health care organizations, and a license is not needed for use. By Mats Lundström This ODM-file contains pre- and post-operative patient froms. To be filled in by patient prior to and within 3 months after surgery. Publication: Mahmud I, Kelley T, Stowell C, et al. A Proposed Minimum Standard Set of Outcome Measures for Cataract Surgery. JAMA Ophthalmol. 2015;133(11):1247–1252. doi:10.1001/jamaophthalmol.2015.2810 For this version of the standard set, semantic annotation with UMLS CUIs has been added.

ICHOM Cataracts - Post-operative Clinical Form - Outcomes

- 4/30/20 - 1 form, 3 itemgroups, 16 items, 1 language
Itemgroups: Administrative Data, Post-operative visual status, Post-operative complications
CATARACTS DATA COLLECTION Version 2.0.1 Revised: March 8th, 2017, International Consortium for Health Outcomes Measurement (ICHOM), Source: http://www.ichom.org/ Notice: This work was conducted using resources from ICHOM, the International Consortium for Health Outcomes Measurement (www.ICHOM.org). The content is solely the responsibility of the authors and does not necessarily represent the official views of ICHOM. Conditions: Symptomatic Cataract | Asymptomatic Cataract Treatment Approaches: Phacoemulsification | Sutured Extracapsular Cataract Extraction | Sutureless Extracapsular Cataract Extraction | Intracapsular Cataract Extraction Scores: Catquest-9SF - The Catquest-9SF is free for all health care organizations, and a license is not needed for use. By Mats Lundström et al. This ODM-file contains the post-operative clinical form. The items are to be filled in with clinical or administrative data, collected within three months after cataract surgery. Publication: Mahmud I, Kelley T, Stowell C, et al. A Proposed Minimum Standard Set of Outcome Measures for Cataract Surgery. JAMA Ophthalmol. 2015;133(11):1247–1252. doi:10.1001/jamaophthalmol.2015.2810 For this version of the standard set, semantic annotation with UMLS CUIs has been added.

Swedish National Quality Registry for Cataracts (NCR Nationella Kataraktregistret) - Formulär 1: Basregistret för 2018 års kataraktoperationer (Base register for 2018 cataract surgeries)

- 1/16/19 - 1 form, 16 itemgroups, 43 items, 2 languages
Itemgroups: Hospital Number, Person Number, Eye to be operated, Preoperative visual acuity, NIKE Indication group, Waiting list entry, Date of surgery, Ocular Comorbidities in eye to be operated, Type of Surgery, Material of Lens, Special Properties of lens, peroperative difficulties, intracameral Antibiotics, Peroperative damage posterior capsule or zonule, Postoperative prophylaxis of inflammation, Surgeon's signature
Swedish National Quality Registry for Cataracts (NCR Nationella Kataraktregistret) Head of Registry: Anders Behndig, Professor, Norrland University Hospital, Umeå, Sweden. Adress of Registry: Nationella Kataraktregistret Landstinget Blekinge 371 81 KARLSKRONA Sweden Source: http://rcsyd.se/kataraktreg/registrering/formular-nationella-kataraktregistret This ODM-File is derived from "Formulär 1: Basregistret för 2018 års kataraktoperationer" (Base register for cataract surgeries of the year 2018). To be filled separately for each eye (even if bilateral surgery on the same day). English translation not validated.

Swedish National Quality Registry for Cataracts (NCR Nationella Kataraktregistret) - Formulär 2A: 2018 års kataraktregistrering - Uppföljningsformulär (Follow-up Form for registering of cataracs in 2018, Part A)

- 7/9/18 - 2 forms, 8 itemgroups, 17 items, 2 languages
Itemgroups: Administrative Data, Hospital number, Eye, Person Identifier, Preoperative K-value, Planned refraktion, Axis length, Lens formula
Swedish National Quality Registry for Cataracts (NCR Nationella Kataraktregistret) Head of Registry: Anders Behndig, Professor, Norrland University Hospital, Umeå, Sweden. Adress of Registry: Nationella Kataraktregistret Landstinget Blekinge 371 81 KARLSKRONA Sweden Source: http://rcsyd.se/kataraktreg/registrering/formular-nationella-kataraktregistret This ODM-File is derived from "Formulär 2A/B: 2018 års kataraktregistrering - Uppföljningsformulär" (Follow-up Form for registering of cataracs in 2018). Part A to be filled after surgery, Part B to be filled when medical checks after the current cataract surgery are not longer needed and glasses can be prescribed, but not later than 3 months after surgery. In practice, the end date is between 6 weeks and 3 months after surgery depending on type of cataract surgery and postoperative course. Attention: All varibales are mandatory. English translation not validated.

Formulär 2B: 2018 års kataraktregistrering - Uppföljningsformulär (Follow-up Form for registering of cataracs in 2018, Part B)

6 itemgroups 23 items

Swedish National Quality Registry for Cataracts (NCR Nationella Kataraktregistret) - Formulär 3A: 2018 års Endoftalmit-Uppföljning (Follow-up Form for Endophthalmitis in 2018, Part A)

- 7/9/18 - 2 forms, 7 itemgroups, 7 items, 2 languages
Itemgroups: Name, Hospital number, Person number, Endophthalmitis diagnosed, Eye, Culture, Responsible physician
Swedish National Quality Registry for Cataracts (NCR Nationella Kataraktregistret) Head of Registry: Anders Behndig, Professor, Norrland University Hospital, Umeå, Sweden. Adress of Registry: Nationella Kataraktregistret Landstinget Blekinge 371 81 KARLSKRONA Sweden Source: http://rcsyd.se/kataraktreg/registrering/formular-nationella-kataraktregistret This ODM-File is derived from "Formulär 3A/B: 2018 års Endoftalmit-uppföjning" (Follow-up Form for Endophthalmitis in 2018). To be filled in case of endophthalmitis after cataract surgery. English translation not validated.

Formulär 3B: 2018 års Endoftalmit-Uppföljning (Follow-up Form for Endophthalmitis in 2018, Part B)

7 itemgroups 22 items

Acrylate Intraocular Lenses in Cataract Surgery of Uveitis Patients - Eligibility

- 6/3/17 - 1 form, 2 itemgroups, 6 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
ODM derived from http://clinicaltrials.gov/ct2/show/record/NCT00403832

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