Comparison of intraocular lenses with distant and near vision used in Cataract Surgery

Category Primary study
Registry of TrialsBrazilian Registry of Clinical Trials
Year 2023
INTERVENTION: E07.632.500.460.250 H26.9 Routine Cataract Surgery with phacoemulsification with implant of Intraocular Lens. 128 individuals divided by simple randomization with Microsoft Excel software into two groups, each with 64 individuals, in which one used the Vivity lens and the other the Symfony lens. Patients do not know which group they belong to. Si Xmonths after surgery, all participants underwent a routine ophthalmological consultation, associated with a defocus curve, contrast sensitivity test, glasses independence and visual phenomena questionnaires, and reading speed test. CONDITION: C11.510 Cataract PRIMARY OUTCOME: It is expected to find similar areas under the defocus curve between the two groups, that is, whose values ??do not differ with statistical significance (p>0.05). The defocus curve of each patient will be obtained by checking the visual acuity of the individuals achieved when purposefully exposed to different eyeglass lenses, in this case between 0 and ‐3.5 diopters. The Area‐under‐the‐curve of the two groups is expected to be similar (p>0.05) INCLUSION CRITERIA: Patients diagnosed with bilateral cataracts. Absence of other ophthalmological pathologies. Corneal astigmatism of up to 1D. Literate. No age limit. both sexes SECONDARY OUTCOME: Binocular visual acuity without correction for distance, intermediate distance (66 cm) and near distance (40 cm) measured in an ophthalmological office. In each situation, a visual acuity value is obtained and an average of each group in each situation will be obtained. The averages of each distance will then be compared between groups. It is expected that the groups are equivalent, that is, not statistically significant (p>0.05) Contrast sensitivity assessed by Pelli‐Robson chart, under photopic conditions (30cd/m2), without glare. The chart assigns a score depending on the patient's performance. An average of each group will be taken and the groups compared to each other. It is expected that the groups are equivalent, that is, not statistically significant (p>0.05) Glasses dependence assessed by specific questionnaire: PRSIQ. The questionnaire will be applied in order to identify daily situations and check if you can perform activities without wearing glasses. One point will be awarded for each activity that does not require glasses and the score will be added to the end of the questionnaire. An average of each group will be taken and compared to each other. It is expected that the groups are equivalent, that is, not statistically significant (p>0.05) Reading speed assessed by validated text: IReST ‐ Brazilian Portuguese version. Each individual's reading time of the same validated text will be measured and the averages of each group will be compared. It is expected that the groups are equivalent, that is, not statistically significant (p>0.05) The frequency of relevant visual disturbances will be assessed using a specific questionnaire, proposed by McAlinden. One point will be assigned for each situation in which disturbance occurs and the score will be added to the end of the questionnaire. An average of each group will be taken and compared to each other. ; It is expected that the groups are equivalent, that is, not statistically significant (p>0.05)
Epistemonikos ID: 4e2f80610207b818650639c7752f8670553667d3
First added on: Feb 20, 2024