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

Comparison of performance of extended depth of focus intraocular lenses

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5wk8nvr
Enrollment
Unknown
Registered
2023-05-15
Start date
2020-09-25
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Interventions

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 individu
H26.9

Sponsors

Faculdade de Medicina de Ribeirão Preto - Universidade de São Paulo
Lead Sponsor
Faculdade de Medicina de Ribeirão Preto - Universidade de São Paulo
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Patients diagnosed with bilateral cataracts. Absence of other ophthalmological pathologies. Corneal astigmatism of up to 1D. Literate. No age limit. both sexes

Exclusion criteria

Exclusion criteria: Other ocular pathologies. Impossibility of performing the surgery in both eyes. Illiteracy. Astigmatism greater than 1D

Design outcomes

Primary

MeasureTime frame
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)

Secondary

MeasureTime frame
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);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);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);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);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)

Countries

Brazil

Contacts

Public ContactMarcelo Fernandes

Faculdade de Medicina de Ribeirão Preto - Universidade de São Paulo

marcelo.caram.fernandes@usp.cbr+55(16)36022523

Outcome results

None listed

Source: REBEC (via WHO ICTRP)