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To quantify and describe patients with a Geographic Atrophy (GA) diagnosis in at least one eye, and the progression to neovascular Age-Related Macular Degeneration (including how many receive Anti-VEGF), or to GA (in the fellow eye only).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with a Geographic Atrophy diagnosis | Patients diagnosed with geographic atrophy (GA) in at least one eye, at least 50 years old with information on laterality, and registered in the Vestrum health database between January 2015 and April 2023. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Visual Acuity (VA) in Participant's Study Eye | Change in visual acuity (VA) in participant's study eye is reported. Study eye is defined as the first eye with the disease, and fellow eye, the participant's second eye. Change in VA was determined by calculating the difference between mean visual acuity (VA) readings at index diagnosis, and mean at another timepoint, assessed yearly for participants with valid VA readings at both timepoints. | From index date of GA diagnosis up to 5 years |
| Number of Participants Who Developed or Progressed to Age-related Macular Degeneration (wAMD) in the Study Eye | Number of participants who developed or progressed to age-related macular degeneration (wAMD) in the study eye is reported. The criteria used to determine progression through development to wAMD was identifying when ICD (International Classification of Diseases) codes for wAMD were present in the study eye. | From index date of GA diagnosis up to 5 years. |
| Number of Participants Who Developed or Progressed to Geographic Atrophy (GA) in the Fellow Eye | Number of participants who developed or progressed to geographic atrophy (GA) in the fellow eye is reported. For patients diagnosed with GA at baseline, the development of GA in the fellow eye was closely monitored over time, with progress tracked for each year. | From index date of GA diagnosis up to 5 years. |
| Change in Lesion Location for Participants With wAMD in Study Eye | Change in lesion location from extrafoveal to subfoveal in participants who developed wAMD in study eye is reported. Lesion location was assessed at index diagnosis and at each year, then stratified by whether a patient developed wAMD in the 5 years post diagnosis. Changes in lesion were calculated as the difference in the number of participants with extrafoveal location at index diagnosis of the study eye, compared to the number of participants with extrafoveal lesion in the study eye at each year. |
| Measure | Description | Time Frame |
|---|---|---|
| Retinal Disease-related Outcomes: Number of Visits Per Quarter in a Year | The retinal disease-related healthcare resource utilization (HCRU) outcome, number of visits by participants per quarter in a year is reported. | Mean number of quarterly visits from 2019 up to 2023. |
| Retinal Disease-related Outcomes: Number of Anti-VEGF Injections Per Quarter |
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Inclusion Criteria:
- All patients ≥50 years, with a GA diagnosis in at least one eye, included in the Vestrum database identified during the study period (January 2015 to April 2023).
Exclusion Criteria:
- Patients without the information of laterality will be excluded.
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US patients ≥50 years, with a Geographic Atrophy diagnosis in at least one eye
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CorEvitas HQ | Waltham | Massachusetts | 02451 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
For more details refer to:
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Only subjects that met all inclusion and none of the exclusion criteria were included. Subjects from the Vestrum database aged 50+ with information on laterality, and a GA diagnosis between January 1, 2015, to April 30, 2023, were analyzed. While both eyes participated in the study, one eye per participant was analyzed for outcome measures.
This was an observational cohort study based on existing data aimed to quantify and describe patients with a diagnosis of geographic atrophy (GA) in at least one eye, the progression to wet or neovascular age-related macular degeneration (wAMD) in both eyes, and the progression to GA in the fellow eye.
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients With Geographic Atrophy (GA) | Patients diagnosed with geographic atrophy (GA) in at least one eye, at least 50 years old with information on laterality, and registered in the Vestrum health database between January 2015 and April 2023. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Patients diagnosed with geographic atrophy (GA) in at least one eye, at least 50 years old, with information on laterality and registered in the Vestrum health database between January 2015 and April 2023.
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients With Geographic Atrophy (GA) | Patients diagnosed with geographic atrophy (GA) in at least one eye, at least 50 years old with information on laterality, and registered in the Vestrum health database between January 2015 and April 2023. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Visual Acuity (VA) in Participant's Study Eye | Change in visual acuity (VA) in participant's study eye is reported. Study eye is defined as the first eye with the disease, and fellow eye, the participant's second eye. Change in VA was determined by calculating the difference between mean visual acuity (VA) readings at index diagnosis, and mean at another timepoint, assessed yearly for participants with valid VA readings at both timepoints. | Participants with GA at the index date and at least one year of follow-up data, with a VA reading at index, and at least one more VA reading at a subsequent follow-up year. The populations were different for each year since patients should have certain follow-up information to contribute to each cohort, and some participants had data in more than one year. Only those participants with VA readings at appropriate timepoints, with appropriate follow up, were analyzed. | Posted | Mean | 95% Confidence Interval | Letters read | From index date of GA diagnosis up to 5 years |
|
Adverse event information was not applicable for this study.
This was an observational study using existing electronic health care records with data retrieved from the Vestrum Health database in the US.
No adverse events were collected on an individual case level as no safety reporting was applicable for the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients With Geographic Atrophy (GA) | Patients diagnosed with geographic atrophy (GA) in at least one eye, at least 50 years old, with information on laterality and registered in the Vestrum health database between January 2015 and April 2023. |
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The Vestrum database used in this study included only data from visits that occurred at the practices contributing to the database, therefore anything occurring during visits to a retinal specialist in a different practice, state, country etc. was not captured. An overall limitation of the dataset is that data is typically entered by the physician, therefore there is no real-time validation of the information entered during the encounter either in terms of completeness or accuracy.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 5, 2023 | Nov 26, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D057092 | Geographic Atrophy |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| From index date of GA diagnosis up to 5 years |
| Change in Lesion Location for Participants With GA in Fellow Eye | Change in lesion location from extrafoveal to subfoveal in participants who developed GA in fellow eye is reported. Lesion location was assessed at index diagnosis and at each year, then stratified by whether a patient developed GA in the 5 years post diagnosis. Changes in lesion were calculated as the difference in the number of participants with extrafoveal location at index diagnosis of the study eye, compared to the number of participants with extrafoveal lesion in the study eye at each year. | From index date of GA diagnosis up to 5 years |
| Occurrence of GA Over Study Period | Incidence and prevalence of GA over time is reported. This endpoint analyzed the yearly counts of newly diagnosed or prevalent cases to help in understanding the progression of the overall disease. | Number of yearly counts of GA from 2018 to 2013, by quarterly average. |
The retinal disease-related healthcare resource utilization (HCRU) outcome, number of anti-vascular endothelial growth factor (anti-VEGF) injections per quarter in a year is reported. |
| Mean number of quarterly anti-VEGF injections from 2019 up to 2023. |
| Retinal Disease-related Outcomes: Number of Participants With Ocular Comorbidities by Year of Follow up | The retinal disease-related HCRU outcome, number of ocular comorbidities by year of follow up is reported. | Total number of participants with ocular comorbidities were documented from index date up to 5 years. |
| HCRU Outcome: Number of Participants With the Medical Procedure of Corneal Transplant | The number of participants with corneal transplant during the observational period is reported. | Total number of participants with corneal transplants were documented from index date up to 5 years. |
| HCRU Outcome: Number of Participants With the Medical Procedure of Incisional Glaucoma Surgery | Number of participants with incisional glaucoma surgery during the observational period is reported. | Total number of participants with incisional glaucoma surgery were documented from index date up to 5 years. |
| HCRU Outcome: Number of Participants With the Medical Procedure of Vitrectomy | Number of participants with vitrectomy during the observational period is reported. | Total number of participants with vitrectomy were documented from index date up to 5 years. |
| Years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| GA laterality | Data on the number of participants with information on laterality and registered in the Vestrum health database between January 2015 and April 2023 is presented. Only participants with available data were included in the analysis. | Count of Participants | Participants |
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| Wet (neovascular) age-related macular degeneration (wAMD) | Data on the number of participants with information on wet (neovascular) age-related macular degeneration and registered in the Vestrum health database between January 2015 and April 2023 is presented. Only participants with available data were included in the analysis. | Count of Participants | Participants |
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| Lesion location at index | Data on the number of participants with information on location of lesion at index in the study eye, and registered in the Vestrum health database between January 2015 and April 2023 is presented. Only participants with available data were included in the analysis. | Count of Participants | Participants |
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| Patients With Geographic Atrophy (GA) |
Patients diagnosed with geographic atrophy (GA) in at least one eye, at least 50 years old, with information on laterality and registered in the Vestrum health database between January 2015 and April 2023. |
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| Primary | Number of Participants Who Developed or Progressed to Age-related Macular Degeneration (wAMD) in the Study Eye | Number of participants who developed or progressed to age-related macular degeneration (wAMD) in the study eye is reported. The criteria used to determine progression through development to wAMD was identifying when ICD (International Classification of Diseases) codes for wAMD were present in the study eye. | Participants with GA at the index date and at least one year of follow-up data, excluding patients with wAMD prior to index. Only participants with appropriate follow up were analyzed. The populations were different for each year since patients should have certain follow-up information to contribute to each cohort, and some participants had data in more than one year. | Posted | Count of Participants | Participants | From index date of GA diagnosis up to 5 years. |
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| Primary | Number of Participants Who Developed or Progressed to Geographic Atrophy (GA) in the Fellow Eye | Number of participants who developed or progressed to geographic atrophy (GA) in the fellow eye is reported. For patients diagnosed with GA at baseline, the development of GA in the fellow eye was closely monitored over time, with progress tracked for each year. | Participants with GA at the index date and at least one year of follow-up data, excluding bilateral patients at index. Only participants with appropriate follow up were analyzed. The populations were different for each year since patients should have certain follow-up information to contribute to each cohort, and some participants had data in more than one year. | Posted | Count of Participants | Participants | From index date of GA diagnosis up to 5 years. |
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| Primary | Change in Lesion Location for Participants With wAMD in Study Eye | Change in lesion location from extrafoveal to subfoveal in participants who developed wAMD in study eye is reported. Lesion location was assessed at index diagnosis and at each year, then stratified by whether a patient developed wAMD in the 5 years post diagnosis. Changes in lesion were calculated as the difference in the number of participants with extrafoveal location at index diagnosis of the study eye, compared to the number of participants with extrafoveal lesion in the study eye at each year. | Participants with GA at index date and five years of follow-up data who developed wAMD in the study eye after the index date. The populations were different for each year since only patients with lesion location information contributed to each cohort. Only participants with appropriate follow up were analyzed. | Posted | Count of Participants | Participants | From index date of GA diagnosis up to 5 years |
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| Primary | Change in Lesion Location for Participants With GA in Fellow Eye | Change in lesion location from extrafoveal to subfoveal in participants who developed GA in fellow eye is reported. Lesion location was assessed at index diagnosis and at each year, then stratified by whether a patient developed GA in the 5 years post diagnosis. Changes in lesion were calculated as the difference in the number of participants with extrafoveal location at index diagnosis of the study eye, compared to the number of participants with extrafoveal lesion in the study eye at each year. | Participants with GA at the index date and five years of follow-up data who developed GA in the fellow eye after the index date. The populations were different for each year since only patients with lesion location information contributed to each cohort. Only participants with appropriate follow up were analyzed. | Posted | Count of Participants | Participants | From index date of GA diagnosis up to 5 years |
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| Primary | Occurrence of GA Over Study Period | Incidence and prevalence of GA over time is reported. This endpoint analyzed the yearly counts of newly diagnosed or prevalent cases to help in understanding the progression of the overall disease. | Participants newly diagnosed with GA by quarterly average per year, for 2018-2023. Given the nature of the database, it was not possible to assess the prevalence or incidence of GA, but the absolute numbers of first time GA diagnosis, which is presented here. | Posted | Number | Number of participants | Number of yearly counts of GA from 2018 to 2013, by quarterly average. |
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| Secondary | Retinal Disease-related Outcomes: Number of Visits Per Quarter in a Year | The retinal disease-related healthcare resource utilization (HCRU) outcome, number of visits by participants per quarter in a year is reported. | Participants were evaluated from the incident date of GA and assessed on a yearly basis for changes in physician habits over time. A patient visit or encounter was identified in the database any time a patient visited one of the panel physicians, without filtering on follow-up information. Results are presented only for first quarters of 2019 to 2023 respectively. | Posted | Mean | Standard Deviation | Mean number of visits per quarter | Mean number of quarterly visits from 2019 up to 2023. |
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| Secondary | Retinal Disease-related Outcomes: Number of Anti-VEGF Injections Per Quarter | The retinal disease-related healthcare resource utilization (HCRU) outcome, number of anti-vascular endothelial growth factor (anti-VEGF) injections per quarter in a year is reported. | Participants were evaluated from index diagnosis and last encounter date, including patients in quarters with no anti-VEGF treatments, without filtering on follow-up information. Results are presented only for first quarters of 2019 to 2023 respectively. | Posted | Mean | Standard Deviation | Mean number of anti-VEGF injections | Mean number of quarterly anti-VEGF injections from 2019 up to 2023. |
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| Secondary | Retinal Disease-related Outcomes: Number of Participants With Ocular Comorbidities by Year of Follow up | The retinal disease-related HCRU outcome, number of ocular comorbidities by year of follow up is reported. | Participants with GA were tracked longitudinally (yearly) from index date of GA diagnosis in the database for occurrence of ocular comorbidities. | Posted | Count of Participants | Participants | Total number of participants with ocular comorbidities were documented from index date up to 5 years. |
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| Secondary | HCRU Outcome: Number of Participants With the Medical Procedure of Corneal Transplant | The number of participants with corneal transplant during the observational period is reported. | Participants with GA were tracked longitudinally (yearly) from index date of GA diagnosis in the database for occurrence of corneal transplantation. | Posted | Count of Participants | Participants | Total number of participants with corneal transplants were documented from index date up to 5 years. |
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| Secondary | HCRU Outcome: Number of Participants With the Medical Procedure of Incisional Glaucoma Surgery | Number of participants with incisional glaucoma surgery during the observational period is reported. | Participants with GA were tracked longitudinally (yearly) from index date of GA diagnosis in the database for occurrence of incisional glaucoma surgery. | Posted | Count of Participants | Participants | Total number of participants with incisional glaucoma surgery were documented from index date up to 5 years. |
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| Secondary | HCRU Outcome: Number of Participants With the Medical Procedure of Vitrectomy | Number of participants with vitrectomy during the observational period is reported. | Participants with GA were tracked longitudinally (yearly) from index date of GA diagnosis in the database for occurrence of vitrectomy. | Posted | Count of Participants | Participants | Total number of participants with vitrectomy were documented from index date up to 5 years. |
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Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
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| Participants with wAMD in 3+ years |
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| Participants with wAMD in 4+ years |
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| Participants with wAMD in 5+ years |
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| Participants with GA in fellow eye in 3+ years |
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| Participants with GA in fellow eye in 4+ years |
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| Participants with GA in fellow eye in 5+ years |
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| Participants with change of lesion location in Year 3 |
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| Participants with change of lesion location in Year 4 |
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| Participants with change of lesion location in Year 5 |
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| Participants with change of lesion location in Year 3 |
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| Participants with change of lesion location in Year 4 |
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| Participants with change of lesion location in Year 5 |
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| Total new diagnosis of GA patients by quarterly average in 2021 |
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| Total new diagnosis of GA patients by quarterly average in 2022 |
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| Total new diagnosis of GA patients by quarterly average in 2023 |
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| Mean number of visits in first quarter of 2021 |
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| Mean number of visits in first quarter of 2022 |
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| Mean number of visits in first quarter of 2023 |
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| Mean number of anti-VEGF injections in first quarter of 2021 |
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| Mean number of anti-VEGF injections in first quarter of 2022 |
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| Mean number of anti-VEGF injections in first quarter of 2023 |
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| Participants with ocular comorbidities in study eye: in the first 3 years |
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| Participants with ocular comorbidities in study eye: in the first 4 years |
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| Participants with ocular comorbidities in study eye: in the first 5 years |
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| Participants with corneal transplant in study eye: In the first 3 years |
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| Participants with corneal transplant in study eye: in the first 4 years |
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| Participants with corneal transplant in study eye: in the first 5 years |
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| Participants with incisional glaucoma surgery in study eye: in the first 3 years |
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| Participants with incisional glaucoma surgery in study eye: in the first 4 years |
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| Participants with incisional glaucoma surgery in study eye: in the first 5 years |
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| Participants with vitrectomy performed on study eye: in the first 3 years |
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| Participants with vitrectomy performed on study eye: in the first 4 years |
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| Participants with vitrectomy performed on study eye: in the first 5 years |
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