Cataract Clinical Trial
— ELVIRA4Official title:
Quality of Life and Uncorrected Binocular Visual Acuity (UBVA) Evaluation in Patients Undergoing Cataract Surgery Using 4 Different Types of Lens Implant Combinations: a Multicenter, Prospective, Comparative and Randomized Study
This is multicenter, prospective, comparative and randomized study focusing on the evolution of the quality of Life and Uncorrected Binocular Visual Acuity (UBVA) evaluation at 3 months after cataract surgery in patients who underwent 4 different types of intraocular lens Implant (IOL) combinations.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | April 30, 2025 |
Est. primary completion date | January 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patient suffering from bilateral cataract and undergoing cataract surgery - Patient with preoperative visual acuity = 8/10th Monoyer (=+ 0.1 logMar) in each eye - Patient with nuclear color (NC), cortical (C) or posterior capsule opacity (P) cataract of normal to severe density in the Lens Opacities Classification System III (LOCSIII) - Patient with cortical cataracts classified C1 to C5 - Patient with cataracts classified as nuclear opalescence (NO)1 to NO4 and nuclear color (NC)1 to NC4 - Patient with posterior capsule opacity cataracts classified as grade 5 (P1-P5) - Patient affiliated to a social security scheme - Patient having given written consent Exclusion Criteria: - Patient with biometrics = 17 Diopters (D) and = 28D - Patient with a history (ATCD) of refractive surgery - Patient with ATCD intraocular surgery - Patient with ATCD strabismus - Patient with amblyopia - Patient with monophthalmos - Patient with age-related macular degeneration (AMD) - Patient with glaucoma - Patient with diabetic retinopathy or maculopathy - Patient with progressive or old ocular inflammatory disease - Patient presenting with a very dense nuclear cataract (Stage NO5-6, NC5-6 on the LOCSIII classification), sources of preoperative complication - Patient with keratoconus - Patient with pseudoexfoliative syndrome - Patient with pigment dispersion - Patient with traumatic cataract - Patient with astigmatism conforming to the rule > 1.5 Diopters (D) or inverse to the rule > 1 Diopter (D) - Patient with abnormal ocular morphology - Patient with abnormal keratometry - Insulin-dependent diabetics and/or diabetics with retinal complications - Pregnant or breastfeeding women - Patient under legal protection (guardianship, curators, safeguard of justice) - Person deprived of liberty - Patient wishing to see near or far exclusively |
Country | Name | City | State |
---|---|---|---|
France | CHR Metz-Thionville/Hopital de Mercy | Metz | |
France | CHR Metz-Thionville_Hopital Bel Air | Metz |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Régional Metz-Thionville |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | National Eye Institute Visual Functioning Questionnaire - 25 (NEI VFQ-25) questionnaire score before cataract surgery | Quality of life score is obtained using the National Eye Institute Visual Functioning Questionnaire - 25 (NEI VQF-25) questionnaire score and measured before intervention.
NEI VFQ-25 questionnaire measures the dimensions of self-reported vision-targeted health status that are most important for persons who have chronic eye diseases. The Visual Function Questionnaire (VFQ-25) consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points (100 is the best score), respectively. |
Few days before surgery | |
Primary | National Eye Institute Visual Functioning Questionnaire - 25 (NEI VFQ-25) questionnaire score 3 months after surgery | Quality of life score is obtained using the National Eye Institute Visual Functioning Questionnaire - 25 (NEI VQF-25) questionnaire score and measured 3 months after intervention.
NEI VFQ-25 questionnaire measures the dimensions of self-reported vision-targeted health status that are most important for persons who have chronic eye diseases. The Visual Function Questionnaire-25 (VFQ-25) consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points (100 is the best score), respectively. |
3 months after surgery | |
Secondary | Uncorrected binocular visual acuity for far vision measured before intervention | Uncorrected binocular visual acuity for distance vision is measured before intervention using Monoyer scale for far vision, scores ranging from 1 to 10, higher scores mean a better outcome; score 10 is the best. | Few days before surgery | |
Secondary | Uncorrected binocular visual acuity for intermediate vision measured before intervention | Uncorrected binocular visual acuity is measured before intervention using Parinaud scale for intermediate vision.
The Parinaud scale ranges from Parinaud 14 (P 14) (lowest score) to Parinaud 1.5 (P 1.5) (best score). |
Few days before surgery | |
Secondary | Uncorrected binocular visual acuity for near vision measured before intervention | Uncorrected binocular visual acuity is measured before intervention using Parinaud scale for near vision.
The Parinaud scale ranges from Parinaud 14 (P 14) (lowest score) to Parinaud 1.5 (P 1.5) (best score). |
Few days before surgery | |
Secondary | Uncorrected binocular visual acuity for far vision measured 4 days postoperatively | Uncorrected binocular visual acuity for far vision is measured 4 days postoperatively using Monoyer scale for far vision, scores ranging from 1 to 10, higher scores mean a better outcome; score 10 is the best. | 4 days after surgery | |
Secondary | Uncorrected binocular visual acuity for intermediate vision measured 4 days postoperatively | Uncorrected binocular visual acuity for intermediate vision is measured 4 days postoperatively using Parinaud scale.
The Parinaud scale ranges from Parinaud 14 (P 14) (lowest score) to Parinaud 1.5 (P 1.5) (best score). |
4 days after surgery | |
Secondary | Uncorrected binocular visual acuity for far vision measured 1 month postoperatively | Uncorrected binocular visual acuity is measured 1 month after surgery using Monoyer scale for far vision, scores ranging from 1 to 10, higher scores mean a better outcome; score 10 is the best. | 1 month after surgery | |
Secondary | Uncorrected binocular visual acuity for intermediate vision measured 1 month postoperatively | Uncorrected binocular visual acuity is measured 1 month after surgery using Parinaud scale.
The Parinaud scale ranges from Parinaud 14 (P 14) (lowest score) to Parinaud 1.5 (P 1.5) (best score). |
1 month after surgery | |
Secondary | Uncorrected binocular visual acuity for near vision measured 1 month postoperatively | Uncorrected binocular visual acuity is measured 1 month after surgery using Parinaud scale.
The Parinaud scale ranges from Parinaud 14 (P 14) (lowest score) to Parinaud 1.5 (P 1.5) (best score). |
1 month after surgery | |
Secondary | Uncorrected binocular visual acuity for far vision measured 3 months postoperatively | Uncorrected binocular visual acuity is measured 3 months after surgery using Monoyer scale for far vision, scores ranging from 1 to 10, higher scores mean a better outcome; score 10 is the best. | 3 months after surgery | |
Secondary | Uncorrected binocular visual acuity for intermediate vision measured 3 months postoperatively | Uncorrected binocular visual acuity for intermediate vision is measured 3 months after surgery using Parinaud scale.
The Parinaud scale ranges from Parinaud 14 (P 14) (lowest score) to Parinaud 1.5 (P 1.5) (best score). |
3 months after surgery | |
Secondary | Uncorrected binocular visual acuity for near vision measured 3 months postoperatively | Uncorrected binocular visual acuity for near vision is measured 3 months after surgery using Parinaud scale.
The Parinaud scale ranges from Parinaud 14 (P 14) (lowest score) to Parinaud 1.5 (P 1.5) (best score). |
3 months after surgery | |
Secondary | Sunglasses wear frequency 3 months after surgery for far and near visions | Frequency of wearing sunglasses in patients undergoing IOL implant surgery : permanently (yes/no) or occasionally (yes/no) for far and near visions | 3 months after surgery | |
Secondary | Eye tonicity before surgery | Eye pressure measurement millimeters of mercury (mmHg) before intervention | Few days before surgery | |
Secondary | Eye tonicity 4 days postoperatively | Eye pressure measurement millimeters of mercury (mmHg) 4 days postoperatively | 4 days after surgery | |
Secondary | Eye tonicity 1 month postoperatively | Eye pressure measurement millimeters of mercury (mmHg) 1 month postoperatively | 1 month after surgery | |
Secondary | Eye tonicity 3 months postoperatively | Eye pressure measurement millimeters of mercury (mmHg) 3 months postoperatively | 3 months after surgery | |
Secondary | Slit lamp and Macular Optical coherence tomography (OCT) examination before surgery | Presence of postoperative complications: Persistent lens mass (Yes/No); Tyndall effect (Yes/No) Hyphema (Yes/No); Irian hernia (Yes/No); Endophthalmitis (Yes/No); Implant dislocation (Yes/No) | Few days before surgery | |
Secondary | Slit lamp and Macular OCT examination 4 days postoperatively | Presence of postoperative complications: Persistent lens mass (Yes/No); Tyndall effect (Yes/No) Hyphema (Yes/No); Irian hernia (Yes/No); Endophthalmitis (Yes/No); Implant dislocation (Yes/No) | 4 days after surgery | |
Secondary | Slit lamp and Macular OCT examination 1 month postoperatively | Presence of postoperative complications: Persistent lens mass (Yes/No); Tyndall effect (Yes/No); Hyphema (Yes/No); Irian hernia (Yes/No); Endophthalmitis (Yes/No); Implant dislocation (Yes/No) | 1 month after surgery | |
Secondary | Slit lamp and Macular OCT examination 3 months postoperatively | Presence of postoperative complications: Persistent lens mass (Yes/No); Tyndall effect (Yes/No); Hyphema (Yes/No); Irian hernia (Yes/No); Endophthalmitis (Yes/No); Implant dislocation (Yes/No) | 3 months after surgery |
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