A clinical trial comparing the effectiveness of simultaneous pterygium excision and phacoemulsification with separate procedures on visual outcomes in patients with concurrent pterygium and cataract

To compare the effectiveness of simultaneous pterygium excision and phacoemulsification with separate procedures on visual outcomes in patients with concurrent pterygium and cataract

This randomized and single-blind clinical trial with parallel and two intervention groups will be conducted on 30 patients who will be randomly selected using the blocks.

Patients will be recruited from Shahid Beheshti Ophthalmology Clinic in Karaj and Karaj Social Security Hospitals. In this single-blind study, sealed opaque envelopes will be used to conceal the sequencing. Intervention group 1 will undergo simultaneous pterygium excision and phacoemulsification, while intervention group 2 will receive the two procedures sequentially, with a one-month interval between surgeries. The person responsible for data collection is blind to group allocation and the type of treatment.

Inclusion Criteria: Age over 50 years; patients diagnosed with cataracts and pterygium; having full consent to participate in the study. Exclusion criteria: Having severe pterygium; having corrected distance visual acuity (CDVA) exceeding 0.15 logMAR; having unreliable refractive measurements; history of ocular surgery or traumatic eye injury, or coexisting ocular pathologies other than pterygium and cataract.

The intervention group 1, Participants will undergo pterygium excision and phacoemulsification in a single operative session. The intervention group 2, Participants will first undergo pterygium excision, followed by phacoemulsification surgery after a one-month interval.

Evaluation and comparison of best corrected visual acuity, astigmatism, and keratometry

Participants will be enrolled by one of the research colleagues. A person, blinded to group allocation will provide a random allocation sequence using computer software of SAS prior to the initiation of the study to be used to randomize participants with 1:1 allocation ratio. A block randomization design (block size of 4, 6) will be applied to ensure an equal number of participants in each group. Group allocation will be concealed in sequentially numbered, opaque, sealed envelopes, and corresponding envelopes will be opened after the enrolled participants are analyzed. In this study the instructor and participants will not be blinded to the group allocation but care provider and responsible for data collection will be blinded to the group allocation.

This study is a single-blind in which both researchers and patients are unaware of the allocation. Upon completion of the study and collection of results, the corresponding codes for each patient will be provided to the specialized team. The single-blind nature of the study was maintained by ensuring that the clinical supervisor and the individual responsible for data collection were not privy to the patients’ allocation. Consequently, the results will be presented anonymously and in a coded format.

The research data obtained from the main outcomes of the study can be shared freely as 'open data'.

6 months after publishing the results

The research data is exclusively accessible to the researchers working at universities and centers for scientific research.

The research data is exclusively accessible to the researchers working at universities and centers for scientific research.

Nima Rastgar Rad provides the data analysis to the applicants via email: rrnima88@gmail.com

Applicants can send emails to him and receive a response within a week.